Carolinas HealthCare System

Research and Clinical Trials

 

Brief Description Principal Investigator
Staphylococcal bacteremia is a serious infection that despite intravenous antibiotic therapy still has a mortality of 20 to 40%. Previous attemopts to augment antibiotic therapy with passive immunization strategies have been met with limited success, due to the presence of the virulence factor, Staphylococcal Protein A (SpA). SpA binds the Fc region of immunoglobulins, effectively neutralizing them, which interferes with complement activation and phagocytosis. Huynh, Toan 

Other Female Genital 

Brief Description Principal Investigator
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer. Crane, Erin King 

Ovary 

Brief Description Principal Investigator
The focus of this study is to evaluate the efficacy, safety, and tolerability of veliparib in women with previously untreated, Stage III or IV, high-grade serous, epithelial ovarian, fallopian tube, or primary peritoneal cancer. Crane, Erin King 

Kidney 

Brief Description Principal Investigator
To Evaluate Safety and Tolerability of Dalantercept Plus Axitinib in Patients with Advanced Renal Cell Carcinoma (RCC) to determine the recommended dose level of Dalantercept plus Axitinib for Part 2. Burgess, Earle Frederick 

Breast - Female 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Colon 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Esophagus 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Lung 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Ovary 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Pancreas 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Soft Tissue 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Urinary Bladder 

Brief Description Principal Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 

Breast - Female 

Brief Description Principal Investigator
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy
White, Richard Laverne 
This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer White, Richard Laverne 

Leukemia, other 

Brief Description Principal Investigator
To evaluate the safety and tolerability of AMG 232.
To determine the maximum-tolerated dose (MTD) of AMG 232.
To define the pharmacokinetics (PK) of AMG 232 in subjects with relapsed/refractory acute myelois leukemias (AMLs).
Grunwald, Michael Richard 

 

Brief Description Principal Investigator
This study compares the outcomes and number of ventilator-free days of patients with acute respiratory distress syndrome (ARDS) treated with Acthar gel versus placebo Huynh, Toan 

MS - Multiple Sclerosis 

Brief Description Principal Investigator
Laquinimod is an investigational drug that has not been approved by regulatory authorities, such as the FDA and is under research. The purpose of this study is to determine the safety and effectiveness of the drug laquinimod in treating Primary Progressive Multiple Sclerosis (PPMS) - specifically, in reducing the loss of brain volume and reducing MS worsening. The study will investigate if daily oral treatment with laquinimod capsules (0.6 mg or 1.5 mg) improves outcomes in PPMS. Conway, Jill 

Brain and Nervous System 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Breast - Female 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Cervix 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Colon 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Esophagus 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Kidney 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Larynx 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Liver 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Lung 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Melanoma, skin 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Multiple Myeloma 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Other Digestive Organ 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Ovary 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Pancreas 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Prostate 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Rectum 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Small Intestine 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Soft Tissue 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Stomach 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Thyroid 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Urinary Bladder 

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun 

Breast - Female 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Colon 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Esophagus 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Lip, Oral Cavity and Pharynx 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Lung 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Melanoma, skin 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Pancreas 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Rectum 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Stomach 

Brief Description Principal Investigator
To investigate the safety and tolerability of selumetinib when given in combination with MEDI4736 to patients with advanced solid malignancies. Kim, Edward Sanghyun 

Lung 

Brief Description Principal Investigator
To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared
to SoC in terms of PFS in patients with NSCLC.
Carrizosa, Daniel Ricardo 

 

Brief Description Principal Investigator
This will be a prospective, non-interventinal, non-invasive observational study to validate interpretation bedside echocardiograms using computer algorithms in critically ill patients. Huynh, Toan 

Other Hematopoietic 

Brief Description Principal Investigator
To characterize the pharmacokinetic profile of rivaroxaban administered as dry powder for suspension formulation. Hinson, Ashley Rebekah Presar 

Lung 

Brief Description Principal Investigator
The primary objective of this trial is to establish statistical equivalence in terms of efficacy (overall response rate (ORR), proportion of patients with Complete Response (CR) plus Partial Response (PR) until 18 weeks of first-line treatemnt with BI 695502 plus chemotherapy versus Avastin plus chmeotherapy, followed by maintenance therapy. Kim, Edward Sanghyun 

Breast - Female 

Brief Description Principal Investigator
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim 

Lung 

Brief Description Principal Investigator
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim 

Pancreas 

Brief Description Principal Investigator
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim 

Stomach 

Brief Description Principal Investigator
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim 

Urinary Bladder 

Brief Description Principal Investigator
The purpose of this study is to evaluate the objective response rate (ORR) of nivolumab monotherapy or nivolumab combined with ipilimumab in subjects with advanced or metastatic tumors. Amin, Asim 

Cervix 

Brief Description Principal Investigator
In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the following tumor types: HPV-positive (SCCHN), HPV-negative (SCCHN), Merkel Cell Carcinoma, Cervical, vaginal, or vulvar cancers. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the following diseases: Metastatic or recurrent nasopharyngeal carcinoma (NPC); Metastatic or Recurrent EBV r Amin, Asim 

Colon 

Brief Description Principal Investigator
In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the following tumor types: HPV-positive (SCCHN), HPV-negative (SCCHN), Merkel Cell Carcinoma, Cervical, vaginal, or vulvar cancers. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the following diseases: Metastatic or recurrent nasopharyngeal carcinoma (NPC); Metastatic or Recurrent EBV r Amin, Asim 

Lip, Oral Cavity and Pharynx 

Brief Description Principal Investigator
In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the following tumor types: HPV-positive (SCCHN), HPV-negative (SCCHN), Merkel Cell Carcinoma, Cervical, vaginal, or vulvar cancers. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the following diseases: Metastatic or recurrent nasopharyngeal carcinoma (NPC); Metastatic or Recurrent EBV r Amin, Asim 

Other Female Genital 

Brief Description Principal Investigator
In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the following tumor types: HPV-positive (SCCHN), HPV-negative (SCCHN), Merkel Cell Carcinoma, Cervical, vaginal, or vulvar cancers. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the following diseases: Metastatic or recurrent nasopharyngeal carcinoma (NPC); Metastatic or Recurrent EBV r Amin, Asim 

Other Skin 

Brief Description Principal Investigator
In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the following tumor types: HPV-positive (SCCHN), HPV-negative (SCCHN), Merkel Cell Carcinoma, Cervical, vaginal, or vulvar cancers. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the following diseases: Metastatic or recurrent nasopharyngeal carcinoma (NPC); Metastatic or Recurrent EBV r Amin, Asim 

Ovary 

Brief Description Principal Investigator
In the neoadjuvant cohort, to investigate the safety and tolerability of neoadjuvant nivolumab administration in the following tumor types: HPV-positive (SCCHN), HPV-negative (SCCHN), Merkel Cell Carcinoma, Cervical, vaginal, or vulvar cancers. In the metastatic/recurrent cohort, to evaluate the investigator-assessed objective response rate (ORR) of nivolumab monotherapy in subjects with the following diseases: Metastatic or recurrent nasopharyngeal carcinoma (NPC); Metastatic or Recurrent EBV r Amin, Asim 

Liver 

Brief Description Principal Investigator
To compare the overall survival (OS) and time to progression (TTP) of nivolumab to sorafenib in subjects with advanced HCC who have not received prior systemic therapy. TTP will be determined from assessments by a blinded independent central review (BICR) based on RECIST 1.1. Hwang, Jimmy John 

Brain and Nervous System 

Brief Description Principal Investigator
Primary: To compare overall survival (OS) of nivolumab plus radiation therapy (RT + Nivolumab) vs temazolomide plus radiation therapy (RT+ TMZ) in subjects with newly-diagnosed GBM and unmethylated MGMT tumors after surgical resection.
Secondary: Compare investigator assessed progression-free survival (PFS) of RT + nibolumab vs RT + TMZ. To estimate overall survival rate at 24 months (OS [24] of RT + nivolumab vs RT + TMZ.
Sumrall, Ashley Love 

 

Brief Description Principal Investigator
Patients with positive cultures for CRE (Cabapenem-Resistant Enterobacteriaceae) will be treated with either plazomicin or colistin (both with added meropenem or tigecycline) for up to 4 days. The study is looking to see if plazomicin is as good or better than the current treatment for CRE. Horton, James 

Lung 

Brief Description Principal Investigator
To evaluate progression free survival (PFS) with nab-paclitaxel as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin in subjects with squamous cell NSCLC. Mileham, Kathryn Finch 
To assess the safety and tolerability of weekly continous nab-paclitaxel (Abraxane®) vs. with 1 week break in combination with Carboplatin as 1st line treatment for advanced NSCLC in elderly subjects >70 years old). Haggstrom, Daniel Ernest 

Pancreas 

Brief Description Principal Investigator
To evaluate the time to treatment failure (TTF) in LAPC subjects treated with
nab-paclitaxel plus gemcitabine as induction therapy followed by Investigator?s
Choice of treatment
Hwang, Jimmy John 

Breast - Female 

Brief Description Principal Investigator
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo 

Lung 

Brief Description Principal Investigator
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo 

Pancreas 

Brief Description Principal Investigator
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory AML measured response within the first 4 cycles of treatment. Kaplan, Joel Adam 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
Primary: Evaluate the effectiveness of lenalidomide as monotherapy or as combination treatment in MCL subjects who have relapsed or progressed after ibrutinub or refractory or intolerant to ibrutinib.
Secondary: Evaluate safety of lenalidomide in MCL subjects who have relapsed or progressed after ibrutinib treatment or are refractory or intolerant to ibrutinib.
Ghosh, Nilanjan 

Lung 

Brief Description Principal Investigator
Phase I: To determine the safety and tolerability, DLTs, MAD or MTD and RP2D of the combination of rociletinib and trametinib when administered to patients with locally advanced or metastatic activating EGFR mutation-positive (EGFRm) NSCLC. To assess the PK profile of rociletinib and trametinib when given in combination.
Phase II: To determine the efficacy of the combination of rociletinib and trametinib based on ORR (CR or PR) per RECIST v1.1 in the following advanced or metastatic EGFRm NSCLC
Mileham, Kathryn Finch 

Soft Tissue 

Brief Description Principal Investigator
The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Kaplan, Joel Adam 

Lymphoid Leukemia 

Brief Description Principal Investigator
The purpose of this study is to establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma at first and subsequent relapse. Kaplan, Joel Adam 
To provide a risk classification scheme for all patients with newly diagnosed ALL, which will be used to assign treatment on Children‟s Oncology Group (COG) frontline ALL treatment studies. To capture classification data for correlative studies accompanying current COG ALL treatment protocols. Kaplan, Joel Adam 
This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia. Kaplan, Joel Adam 
This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia, testing Clofarabine (IND#73789, NSC#606869) in the very-high risk stratum. Kaplan, Joel Adam 

Ill-Defined Sites 

Brief Description Principal Investigator
To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.
The primary goal in this trial is to prevent relapse. AALL1231 will test two major strategies to meet this goal: (1) to modify the existing chemotherapy platform to mirror the most efficacious backbone that has been tested in Phase 3 trials; and, (2) to randomize patients to receive/not receive a novel agent (bortezomib), with strong b
Kaplan, Joel Adam 

Leukemia, not otherwise specified 

Brief Description Principal Investigator
To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.
The primary goal in this trial is to prevent relapse. AALL1231 will test two major strategies to meet this goal: (1) to modify the existing chemotherapy platform to mirror the most efficacious backbone that has been tested in Phase 3 trials; and, (2) to randomize patients to receive/not receive a novel agent (bortezomib), with strong b
Kaplan, Joel Adam 

Lymphoid Leukemia 

Brief Description Principal Investigator
To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.
The primary goal in this trial is to prevent relapse. AALL1231 will test two major strategies to meet this goal: (1) to modify the existing chemotherapy platform to mirror the most efficacious backbone that has been tested in Phase 3 trials; and, (2) to randomize patients to receive/not receive a novel agent (bortezomib), with strong b
Kaplan, Joel Adam 

Leukemia, other 

Brief Description Principal Investigator
Primary Aims
1. To compare disease free survival (DFS) of high risk (HR) and intermediate risk (IR) relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy (standard chemotherapy) to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization).

2. To compare DFS of low risk (LR) relapse B-ALL patients who are randomized following Block 1 chemotherapy (standard chemotherapy) to receive either chemotherapy alone or che
Kaplan, Joel Adam 

Ill-Defined Sites 

Brief Description Principal Investigator
Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future. Kaplan, Joel Adam 

Unknown Sites 

Brief Description Principal Investigator
To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. Kaplan, Joel Adam 

Brain and Nervous System 

Brief Description Principal Investigator
The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. Kaplan, Joel Adam 
This randomized phase III trial is studying different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor. Kaplan, Joel Adam 
This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Kaplan, Joel Adam 
To determine the objective response rate in children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with Regimen A low-dose (20 mg/m²/dose) or Regimen B high-dose (115 mg/m²/dose) lenalidomide. Kaplan, Joel Adam 

Bones and Joints 

Brief Description Principal Investigator
The purpose of this study is to collect biological specimens, including associated demographic and clinical data, from patients with Ewing sarcoma. Kaplan, Joel Adam 
Primary Objective
To compare the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479).
Kaplan, Joel Adam 

Soft Tissue 

Brief Description Principal Investigator
Primary Objective
To compare the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479).
Kaplan, Joel Adam 

Liver 

Brief Description Principal Investigator
This phase III trial is studying the side effects of giving doxorubicin hydrochloride together with combination chemotherapy and to compare different chemotherapy regimens to see how well they work in treating young patients with newly diagnosed liver cancer. Kaplan, Joel Adam 

Hodgkin's Lymphoma 

Brief Description Principal Investigator
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of brentuximab vedotin in combination with gemcitabine (gemcitabine hydrochloride) administered every three weeks to children with relapsed or primary refractory Hodgkin lymphoma (HL).

II. To define and describe the toxicities of brentuximab vedotin in combination with gemcitabine administered on this schedule.

III. To determine the complete response (CR) rate after treatment with four cycl
Kaplan, Joel Adam 
1.1 Primary Aims
1.1.1 To assess the event free survival (EFS) of a novel regimen incorporating brentuximab vedotin (Bv; AdcetrisTM) in the chemotherapy backbone of doxorubicin (Adriamycin), vincristine, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) in newly diagnosed high-risk cHL compared to those treated with ABVE-PC.
Kaplan, Joel Adam 

Unknown Sites 

Brief Description Principal Investigator
The purpose of this study is to institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological and behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points in children with medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET). Kaplan, Joel Adam 

Soft Tissue 

Brief Description Principal Investigator
The purpose of this study is to evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Kaplan, Joel Adam 

Ill-Defined Sites 

Brief Description Principal Investigator
1.1 Primary Aims

1.1.1 To eliminate therapy as the initial approach for infants < 12 months of age with small International Neuroblastoma Risk Group (INRG) Stage L1 neuroblastoma while maintaining an overall survival (OS) of 99%.

1.1.2 To eliminate therapy as the initial approach for non-high-risk patients < 18 months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of 99%.

1.1.3 To achieve a 3-year OS of > 81% for i
Kaplan, Joel Adam 
I. To determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99).

II. To estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and Arm crizotinib (CZ) and contrast these to historical control data.
Kaplan, Joel Adam 

Bones and Joints 

Brief Description Principal Investigator
The purpose of this trial is to collect biological specimens from patients with osteosarcoma at Children?s Oncology Group (COG) institutions. Kaplan, Joel Adam 

Anus 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Bones and Joints 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Brain and Nervous System 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Breast - Female 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Cervix 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Colon 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Corpus Uteri 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Esophagus 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Eye and Orbit 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Hodgkin's Lymphoma 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Ill-Defined Sites 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Kaposi's sarcoma 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Kidney 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Larynx 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Leukemia, not otherwise specified 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Leukemia, other 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Lip, Oral Cavity and Pharynx 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Liver 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Lung 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Lymphoid Leukemia 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Melanoma, skin 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Multiple Myeloma 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Mycosis Fungoides 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Digestive Organ 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Endocrine System 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Female Genital 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Hematopoietic 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Male Genital 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Respiratory and Intrathoracic Organs 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Skin 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Other Urinary 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Ovary 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Pancreas 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Prostate 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Rectum 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Small Intestine 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Soft Tissue 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Stomach 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Thyroid 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Unknown Sites 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Urinary Bladder 

Brief Description Principal Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 

Kidney 

Brief Description Principal Investigator
The purpose of this study is to classify patients with renal tumors by histological categorization, surgicopathological stage, presence of metastases, age at diagnosis, tumor weight and loss of heterozygosity for chromosomes 1p and 16q, to thereby define eligibility for a series of therapeutic studies. Kaplan, Joel Adam 

Soft Tissue 

Brief Description Principal Investigator
The first part of the study will determine the feasibility of adding pazopanib in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk (Non-Rhabdomyosarcoma Soft Tissue Sarcomas) NRSTS.

The second part of the study will compare the rates of response of (1) preoperative pazopanib plus chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, Grade 3 intermediate to high risk ch
Kaplan, Joel Adam 

 

Brief Description Principal Investigator
The purpose of this study is to collect additional information about the performance and safety of the Gunther Tulip filter and the Celect filters. Sing, Ronald 

ALS - Amyotrophic Lateral Sclerosis 

Brief Description Principal Investigator
The research study involves an investigational drug called tirasemtiv which is being investigated as a potential new therapy for the improvement of muscle weakness and muscle fatigue in patients with ALS (Amyotrophic Lateral Sclerosis). The purpose of the study is to assess the effect of tirasemtiv versus placebo on respiratory function but will also evaluate the safety, tolerability and efficacy of tirasemtiv when taken with or without riluzole. Time will be 60 weeks, 16 study visits. Brooks, Benjamin 

Multiple Myeloma 

Brief Description Principal Investigator
Primary: To estimate the response rate after 4 cycles in subjects treated with elotuzumab plus bortezomib, lenalidomide and dexamethseone (E-RVD).
Secondary:
To estimate # of subjects with stem cell mobilization after 4 cycles ERVD.
To estimate # of subjects requiring dose modification of study drug ERVD.
To characterize safety profile of ERVD.
To provide information on activity of ERVD on BR, ORR, PFS
Usmani, Saad Zafar 

 

Brief Description Principal Investigator
Randomized, double-blind, placebo-controlled parallel group outpatient study that utilizes standard stroke rehabilitation outcome measures, as well as fMRI tecniques to evaluate the effect of study drug, monoamine oxidase Type B (MAO-B) inhibitor, HT-3951, on motor recovery and behavior in medically stable subjects following ischemic stroke. Nguyen, Vu 

Lung 

Brief Description Principal Investigator
The primary objective of this study is to evaluate the safety and tolerability of LY2835219 when administered orally in combination with multiple single-agent options to patients with Stage IV non-small cell lung cancer (NSCLC) using Common Terminology Criteria for Adverse Events (CTCAE version 4.0, NCI 2009). The secondary objectives of the study are to determine the pharmacokinetics (PK) of LY2835219 when given in combination with multiple single-agent options; to document the antitumor activ Kim, Edward Sanghyun 

 

Brief Description Principal Investigator
This study is to assess the safety and the efficacy of 2 doses of once daily EVP-6124 tablets (1 and 2 mg) as an adjunctive pro-cognitive treatment, versus placebo, when added to chronic, stable, atypical anti-psychotic therapy in subjects with schizophrenia Tcheremissine, Oleg 

Multiple Sclerosis 

Brief Description Principal Investigator
To evaluate the effectiveness and safety of BAF312 compred to placebo (a substance that looks like BAF312 but does not contain any active ingredient) in people with secondary progressive multiple sclerosis (SPMS). Your participation will last for 23 to 42 months, but no more than 60 months, depending on when you enroll in the study. You would be randomized (put in a group by a chance process, like flipping a coin) to receive either BAF312 or placebo. BAF312. Conway, Jill 

Leukemia, other 

Brief Description Principal Investigator
To determine the maximum tolerated dose (MTD), the dose limiting toxicities(DLT) and the dose of FT-1101 recommended for future phase 2 studies (RP2D) for patients with relapsed refractory acute leukemia or high-risk MDS. Grunwald, Michael Richard 

Other Hematopoietic 

Brief Description Principal Investigator
To determine the maximum tolerated dose (MTD), the dose limiting toxicities(DLT) and the dose of FT-1101 recommended for future phase 2 studies (RP2D) for patients with relapsed refractory acute leukemia or high-risk MDS. Grunwald, Michael Richard 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
Primary:
To assess the safety and tolerability of the combination of polatuzumab vedotin with BR or BG when administered to patients with R/R FL or DLBCL
To identify the RP2D for polatuzumab vedotin given in combination with BR or with BG in patients with R/R FL or DLBCL
Ghosh, Nilanjan 

Urinary Bladder 

Brief Description Principal Investigator
The primary efficacy objective for this study is to evaluate the efficacy of adjuvant MPDL3280A treatment in patients with PD- L1−selected muscle invasive bladder cancer (MIBC), as measured by disease-free survival (DFS) Burgess, Earle Frederick 

Breast - Female 

Brief Description Principal Investigator
The primary efficacy objective is to estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with early stage TNBC, as measured by local pathology laboratory evaluation of pCR rate within the breast and exilla (ypT0/Tis ypN0) in all patients and in patients with PTEN-low tumors. Fisher, Julie Gottlieb 

HIV 

Brief Description Principal Investigator
A study for HIV-1 infected individuals currently taking Complera® with an undectable viral load. Complera will be compared to an investigational fixed dose combination (FDC) tablet containing FTC/RPV/TAF. The trial is not only measuring the effectiveness of the medication to suppress viral load, but also comparing the side effects of the two medications. Patients will be asked to follow-up for at least one year. Fixed Dose Combination tablets help to decrease the pill burden for patients. Johnson, Marc 
HIV treatment experienced study looking at those on a current regimen containing EFV/FTC/TDF FDC (Atripla) to continue treatment, versus switching to FTC/RPV/TAF FDC. Polk, Christopher 

Lung 

Brief Description Principal Investigator
To assess the safety and tolerability of the combination of PEGPH20 with docetaxel (PDoc).
To determine the recommended Phase 2 dose (RP2D) of PDoc.
To determine the recommended Phase 2 schedule of PDoc in subjects whose tumors have high levels of HA (high-HA).
Haggstrom, Daniel Ernest 

HIV 

Brief Description Principal Investigator
The purpose of this study is to determine if an investigational treatment regimen of BMS-663068 (BMS Attachment Inhibitor) twice a day, plus other antiretroviral medications used in combination is safe and effective for the treatment of subjects who are infected with Human Immunodeficiency Virus (HIV-1). HIV positive subjects in this research study must be "Heavily Treatment Experienced". This means you must have taken many HIV medications during the history of your disease. Johnson, Marc 

spinal cord injury¸ ventilator dependent 

Brief Description Principal Investigator
A device which allows patients, 18 years of age and older, to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. The device electrically stimulates the diaphragm and maintains adequate ventilation for patients with upper motor neuron respiratory paralysis (C1-C2), related to spinal cord injury, whose remaining Phrenic nerve, lung and diaphragm functions are normal. When stimulated by the pacer the diaphragm contracts which mimics natural breathing an Bockenek, William 

Lung 

Brief Description Principal Investigator
Looking at the safety and efficacy of a once daily inhaled triple medication therapy for patients with COPD. The triple combination will be compared to the current market available dual combiniation therapies. Patients who qualify will be assigned to either the investigational product or one of the dual therapies. They will be followed for 52 weeks and have approximately 7 clinic visits. Patients will be asked to keep a daily diary of their respiratory symptoms on a provided hand-held device. Zgoda, Michael 

Other Hematopoietic 

Brief Description Principal Investigator
Describe the clinical burden of polycythemia vera (PV)
Describe healthcare resource utilization associated with the management of PV
Grunwald, Michael Richard 

MS - Multiple Sclerosis 

Brief Description Principal Investigator
To find out if BG00012 (also known as Tecfidera or dimethyl fumarate) is effective in slowing the progression of disability in people with SPMS. The safety of BG00012, how well people tolerate it, and the effect it may have on the results of tests and evaluations used to assess SPMS. It will also look at the effect of BG00012 on biomarkers (naturally occuring substances in the body - e.g., proteins, ribonucleic acid {RNA} in the blood. Graves, Donna 

Other Urinary 

Brief Description Principal Investigator
To evaluate the objective response rate of the selected dose regimen out of 2 possible dose regimens (Regimen 1: 10 mg dose, 7 days on/7 days off; and Regimen 2: 6 mg dose, 21 days on/7 days off) in subjects with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations. Burgess, Earle Frederick 

Urinary Bladder 

Brief Description Principal Investigator
To evaluate the objective response rate of the selected dose regimen out of 2 possible dose regimens (Regimen 1: 10 mg dose, 7 days on/7 days off; and Regimen 2: 6 mg dose, 21 days on/7 days off) in subjects with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations. Burgess, Earle Frederick 

Multiple Myeloma 

Brief Description Principal Investigator
To evaluate the pharmacokinetics, safety, and tolerability of SC delivery of daratumumab (Part 1).
To compare the pharmacokinetics, safety, and tolerability of SC and IV delivery of daratumumab (Part 2).
Usmani, Saad Zafar 
Progression-Free Survival (PFS) Time (Time Frame: From baseline for the duration of disease follow-up, with an expected average of 40 months)
The PFS is defined as time from date of randomization to either progressive disease (PD), or death, whichever occurs first. PD will be determined according to International Myeloma Working Group (IMWG) criteria.
Usmani, Saad Zafar 
Primary Objective: The primary objective of the study is to evaluate the safety, tolerability (including dose-limiting toxicity [DLT]), and dosing of daratumumab when administered to subjects with multiple myeloma in combination with various treatment regimens: VELCADE-dexamethasone (VD), VELCADE-melphalan-prednisone (VMP), pomalidomide-dexamethasone (Pom-dex), and VELCADE-thalidomide-dexamethasone (VTD).
Additional Primary Objectives added to Amendment INT-5: The primary objective of the carfi
Usmani, Saad Zafar 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
Primary
Part I: Evaluate efficacy and safety of imetelstat in transfusion dependent subjects with low/ intermediate-I risk MDS that is relapsed/ refratory to ESA treatment.
Part I: To compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in tranfusion dependent subjects with low or intermediate-I risk MDS that is relapsed/ refractory to ESA treatment.
Grunwald, Michael Richard 

Leukemia, other 

Brief Description Principal Investigator
Primary: Evaluate spleen response rate and symptom response rate of 2 dose regimens of imetelstat in subjects with intermediate-2 or high-risk MF who are relapsed after or refractory to JAK inhibitor treatment. Grunwald, Michael Richard 

Colon 

Brief Description Principal Investigator
Estimate PFS in previously untreated mCRC patients receiving FOLFIRI + bevacizumab when irinotecan dose is based on UGT1A1 genotype Patel, Jai Narendra 

Rectum 

Brief Description Principal Investigator
Estimate PFS in previously untreated mCRC patients receiving FOLFIRI + bevacizumab when irinotecan dose is based on UGT1A1 genotype Patel, Jai Narendra 

Leukemia, not otherwise specified 

Brief Description Principal Investigator
To determine the ability of CD34+ cell selection using the CliniMACS® device as the sole
GVHD prophylaxis to prevent severe (grade III-IV) acute GVHD in recipients of
alternative donor (mismatched related donor and unrelated donor) hematopoietic stem
cell transplants.
Gilman, Andrew Lee 

Leukemia, other 

Brief Description Principal Investigator
To determine the ability of CD34+ cell selection using the CliniMACS® device as the sole
GVHD prophylaxis to prevent severe (grade III-IV) acute GVHD in recipients of
alternative donor (mismatched related donor and unrelated donor) hematopoietic stem
cell transplants.
Gilman, Andrew Lee 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
To determine the ability of CD34+ cell selection using the CliniMACS® device as the sole
GVHD prophylaxis to prevent severe (grade III-IV) acute GVHD in recipients of
alternative donor (mismatched related donor and unrelated donor) hematopoietic stem
cell transplants.
Gilman, Andrew Lee 

Other Hematopoietic 

Brief Description Principal Investigator
To determine the ability of CD34+ cell selection using the CliniMACS® device as the sole
GVHD prophylaxis to prevent severe (grade III-IV) acute GVHD in recipients of
alternative donor (mismatched related donor and unrelated donor) hematopoietic stem
cell transplants.
Gilman, Andrew Lee 
To assess the ability of a donor lymphocyte infusion given with methotrexate GVHD prophylaxis to accelerate immune recovery following transplantation of a CD34+selected, T cell-depleted stem cell product. Gilman, Andrew Lee 

Breast - Female 

Brief Description Principal Investigator
Primary: to compare radioactive seed localization (RSL) and wire-guided localization (WL) based on negative margins in malignant disease where negative margins is defined as no tumor on ink in invasive disease, and greater than or equal to 2mm from the inked margin in non-invasive disease (DCIS).
Secondary: to compare RSL and WL base on the following: total procedure cost, subject satisfaction over time, time from subject consult to operating room, radiologist satisfaction, time in radiology, s
Hadzikadic-Gusic, Lejla 

Ill-Defined Sites 

Brief Description Principal Investigator
The purpose of this study is to collect retrospective and prospective clinical data elements on all patients diagnosed and/or treated at LCI locations. Raghavan, Derek 

Pancreas 

Brief Description Principal Investigator
Primary: To assess the potential benefit of regorafenib in the treatment of advanced previously-treated pancreatic cancer.
Secondary: Critical examination of Response Rate (RR), Disease Control Rate (DCR, defined as CR+Pr+SD), Overall Survival (OS), and toxicity.
Exploratory: Tissue and blood samples will be collected for exploratory biomarker analyses.
Salmon, John Stuart 

Urinary Bladder 

Brief Description Principal Investigator
Primary: To assess the overall response rate (ORR) of crizotinib in patients with c-MET or RON-positive advanced urothelial carcinoma previously treated with a platinum-based regimen.
Secondary: To assess overall survival (OS), progression-free survival (PFS), and the safety and toxicity profile with this regimen.
Exploratory: To correlate c-MET and RON expression patterns with response rate, PFS, and OS, and to perform additional genomic analysis on select patients in the future.
Burgess, Earle Frederick 

Hodgkin's Lymphoma 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Leukemia, not otherwise specified 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Lymphoid Leukemia 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Multiple Myeloma 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Other Hematopoietic 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Unknown Sites 

Brief Description Principal Investigator
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 

Multiple Myeloma 

Brief Description Principal Investigator
Primary: To collect high quality biospecimens to study plasma cell disorders.
Exploratory: 1. To determine the differences between precurser states and multiple myeloma using gene expression data, DNA sequencing, RNA studies, epigenetics, proteomics, metabolomics, pathway analysis, and immunophenotypic analysis. 2. To standardize MRD assays and validate prognostic MRD thesholds for MRD monitoring as a tool for risk-adapted clinical trials. 3. To evaluate biomarkers and immune markers associated
Bhutani, Manisha 

Other Hematopoietic 

Brief Description Principal Investigator
Primary: To collect high quality biospecimens to study plasma cell disorders.
Exploratory: 1. To determine the differences between precurser states and multiple myeloma using gene expression data, DNA sequencing, RNA studies, epigenetics, proteomics, metabolomics, pathway analysis, and immunophenotypic analysis. 2. To standardize MRD assays and validate prognostic MRD thesholds for MRD monitoring as a tool for risk-adapted clinical trials. 3. To evaluate biomarkers and immune markers associated
Bhutani, Manisha 

Leukemia, not otherwise specified 

Brief Description Principal Investigator
Primary:
1.0 To obtain high quality and germline tissue from patients with myeloid hematologic malignancies in pre-malignant conditions. This material will be used for a variety of genetic analyses aimed at identification of novel mutations involved in the initiation and progression of these diseases.

Exploratory:
1.0 To sequence AML genomes for the discovery of mutations or germline variants.

2.0 To identify inherited genetic polymorphisms or mutations in germline DNA that increase susc
Avalos, Belinda Rene 

Lung 

Brief Description Principal Investigator
Primary:
To assess the response rate of the combination of carboplatin and abraxane in patients with advanced non-small cell lung cancer (NSCLC).
Secondary:
To assess the disease control rate, duration of response, duration of disease control, overall survival, progression-free survival, and the safety and toxicity profile with this regimen.
Exploratory:
To assess broad molecular profiling.
Mileham, Kathryn Finch 

Brain and Nervous System 

Brief Description Principal Investigator
Primary Objective
The primary objective of this phase II study is to assess the efficacy of a treatment regimen that involves the administration of temozolomide and bevacizumab with concurrent use of the medical device, NovoTTF?-100A System, by evaluating the percentage of newly diagnosed unresectable glioblastoma (GBM) patients who are alive at 12 months.

Secondary Objective
- Evaluate progression free survival (PFS)
- Evaluate overall response rate (ORR) and disease control rate (DCR)
Sumrall, Ashley Love 

Ill-Defined Sites 

Brief Description Principal Investigator
Primary: To determine the percentage of subjects achieving significant pain improvement over a one month period (greater than or equal to a 2 point decrease from baseline pain score on an 11 point scale [0-10]) in oncology outpatients receiving pharmacogenomic testing.

Secondary: a) To determine the success rate of achieving significant pain improvement at Assessment #2 (i.e. after initial pharmacogenomic-driven therapy selection) as measured from pain score at Assessment #1 in subjects who
Patel, Jai Narendra 

Lung 

Brief Description Principal Investigator
Part A Objective:
The primary objective of Part A is to assess the safety and tolerability of ramucirumab when administered in
combination with erlotinib as therapy in previously untreated patients with EGFR mutation-positive metastatic
NSCLC.
Part B:
Primary Objectives:
The primary objective of Part B is to compare PFS of ramucirumab administered in combination with erlotinib versus
placebo in combination with erlotinib as therapy in previously untreated patients with EGFR mutation-posit
Mileham, Kathryn Finch 

Esophagus 

Brief Description Principal Investigator
Evaluate ramucirumab PK following various dose regimens. Assess the safety for each dose group of ramucirumab in patients with advanced gastric cancer, whose disease has progressed during or following prior combination chemotherapy. Hwang, Jimmy John 

Stomach 

Brief Description Principal Investigator
Evaluate ramucirumab PK following various dose regimens. Assess the safety for each dose group of ramucirumab in patients with advanced gastric cancer, whose disease has progressed during or following prior combination chemotherapy. Hwang, Jimmy John 

Soft Tissue 

Brief Description Principal Investigator
The primary objective is to compare doxorubicin plus olaratumab versus doxorubicin plus placebo with respect to OS in patients with advanced or metastatic soft tissue sarcoma (STS) which is not amenable to treatment with surgery or radiotherapy with curative intent. Kim, Edward Sanghyun 

Alzheimer´s Disease 

Brief Description Principal Investigator
This study is to assess solanezumab, administered as an intravenous infusion at a dose of 400 mg every 4 weeks for 76 weeks, will slow the cognitive and functional decline of Alzheimer's disease as compared with placebo in patients with mild Alzheimer's disease. Tcheremissine, Oleg 

liver/pancreas diseases 

Brief Description Principal Investigator
The purpose of this study is to create and maintain a repository of human biological materials and selected de-identified demographic information for future relevant research purposes. Bonkovsky, Herbert 

Breast - Female 

Brief Description Principal Investigator
The primary objective is to assess the safety, describe the DLTs, and determine the MTD or the maximum administered dose (MAD; in the absence of exceeding the MTD) for MEDI4276 administered as a single agent in subjects with HER2-expressing advanced breast or gastric cancer refractory to standard therapy or for which no standard therapy exists. Tan, Antoinette Roslyn 

Stomach 

Brief Description Principal Investigator
The primary objective is to assess the safety, describe the DLTs, and determine the MTD or the maximum administered dose (MAD; in the absence of exceeding the MTD) for MEDI4276 administered as a single agent in subjects with HER2-expressing advanced breast or gastric cancer refractory to standard therapy or for which no standard therapy exists. Tan, Antoinette Roslyn 

Breast - Female 

Brief Description Principal Investigator
To evaluate the objective response rate (ORR) to pembrolizumab as 2L+ monotherapy in subjects with PD-L1(+)high centrally confirmed mTNBC, based on RECIST 1.1 as assessed by central radiology review. Tan, Antoinette Roslyn 

Traumatic Brain Injury (TBI) 

Brief Description Principal Investigator
To explore the use of platelet mitochondrial dysfunction as minimally invasive biomarker for organ dysfunction following traumatic brain injury. To characterize the relationship between mitochondrial dysfunction and functional outcome following TBI. Evans, Susan 

HIV 

Brief Description Principal Investigator
This trial is comparing a new single tablet combination medication (MK-1439A) to Atripla in HIV patients who are treatment naïve (never been on medications). Johnson, Marc 
This trial is comparing the safety and efficacy of a new single tablet regimen (MK1439A) to current PI boosted regimen in HIV infected adults that are suppressed on their medications. Johnson, Marc 

Lung 

Brief Description Principal Investigator
This registry is intended to measure the effect of myPlan Lung Cancer? test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC.

Mileham, Kathryn Finch 

 

Brief Description Principal Investigator
Phase III, placebo controlled study to investigate the safety and efficacy of the study drug AB103 in patients with a necrotizing soft tissue infection Green, John 

Leukemia, not otherwise specified 

Brief Description Principal Investigator
The primary objective of this study is to examine the incidence of neutrophil recovery of > or = to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Gilman, Andrew Lee 

Leukemia, other 

Brief Description Principal Investigator
The primary objective of this study is to examine the incidence of neutrophil recovery of > or = to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Gilman, Andrew Lee 

Lymphoid Leukemia 

Brief Description Principal Investigator
The primary objective of this study is to examine the incidence of neutrophil recovery of > or = to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Gilman, Andrew Lee 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
The primary objective of this study is to examine the incidence of neutrophil recovery of > or = to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Gilman, Andrew Lee 

Other Hematopoietic 

Brief Description Principal Investigator
The primary objective of this study is to examine the incidence of neutrophil recovery of > or = to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Gilman, Andrew Lee 

Ill-Defined Sites 

Brief Description Principal Investigator
To test the ability of using tumor samples to determine the tumor?s gene expression profile and mutations to make real-time treatment decisions for children with relapsed/refractory cancers. Oesterheld, Javier E 
The purpose of this trial is to test the safety of nifurtimox in children with relapsed or refractory neuroblastoma or medulloblastoma in combination with cyclophosphamide/topotecan. Oesterheld, Javier E 

Brain and Nervous System 

Brief Description Principal Investigator
To evaluate the efficacy of difluoromethylornithine (DFMO) as a single agent in preventing relapse in patients with high-risk neuroblastoma who are in remission, based upon: Event free survival (EFS) from time of enrollment. Oesterheld, Javier E 

Lung 

Brief Description Principal Investigator
To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with
INC280 in patients with cMET positive NSCLC patients
Mileham, Kathryn Finch 

Breast - Female 

Brief Description Principal Investigator
To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. Vallabhaneni, Geetha 
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer. Sharp, Hadley Jean 
The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS). Tan, Antoinette Roslyn 

Colon 

Brief Description Principal Investigator
To identify subpopulations of registry patients on the basis of their molecular profiles that may be eligible for participation in available NSABP clinical trials involving novel agents. Hwang, Jimmy John 

Rectum 

Brief Description Principal Investigator
To identify subpopulations of registry patients on the basis of their molecular profiles that may be eligible for participation in available NSABP clinical trials involving novel agents. Hwang, Jimmy John 

Leukemia, other 

Brief Description Principal Investigator
To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL. Oesterheld, Javier E 

Lymphoid Leukemia 

Brief Description Principal Investigator
To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL. Oesterheld, Javier E 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL. Oesterheld, Javier E 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL. Oesterheld, Javier E 

Ill-Defined Sites 

Brief Description Principal Investigator
To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy). Oesterheld, Javier E 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy). Oesterheld, Javier E 

Soft Tissue 

Brief Description Principal Investigator
Primary Objectives and Endpoints
1.1.1 To evaluate the safety and tolerability of ODSH in pediatric patients receiving ?ICE? (Ifosfamide mixed with Mesna, Carboplatin and Etoposide) chemotherapy.

1.1.2 To evaluate preliminary evidence of an effect of ODSH on time to platelet recovery, defined as when the platelet count remained > 100,000 after nadir for two consecutive days in the absence of a prior platelet transfusion within the previous 48 hours in pediatric patients receiving ?ICE? c
Oesterheld, Javier E 

Leukemia, other 

Brief Description Principal Investigator
Phase 1b
Primary Objectives
1. To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL)

2. To determine the maximum tolerated dose (MTD) of carfilzomib in combination with induction chemotherapy

Phase 2
Primary Objective
1. To estimate the combined rate of bone marrow complete response (CR) and bone marrow CR without platelet recovery (CRp) at
Oesterheld, Javier E 

 

Brief Description Principal Investigator
Subjects 18 to 55 years of age will be randomly assigned to take ponesimod or teriflunomide (Aubagio) pills daily; they have an equal chance of getting either treatment. The treatment will last for 108 weeks. An end-of-treatment visit will take place at Week 108. All subjects will enter the safety follow-up period (2 to 4 weeks). For an individual subject, the maximum duration of the study will be approximately 118 weeks (2.2 years). Conway, Jill 

Ill-Defined Sites 

Brief Description Principal Investigator
To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia at one and two-years following allogeneic HCT for hematologic malignancy. Gilman, Andrew Lee 

Leukemia, other 

Brief Description Principal Investigator
To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia at one and two-years following allogeneic HCT for hematologic malignancy. Gilman, Andrew Lee 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
To evaluate the efficacy of ibrutinib in combination with lenalidomide with or without rituximab by assessing the overall response in subjects with relapsed or refractory non-GCB DLBCL. Ghosh, Nilanjan 

ALS - Amyotrophic Lateral Sclerosis 

Brief Description Principal Investigator
The purpose of this study is to find out whether a high fat or high calorie diet is safe and can be tolerated by people with amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disorder that usually leads to death in 2 to 5 years. Rapid weight loss is a hallmark of the disease, due to inadequate caloric intake and, in 80% of patients, a hypermetabolic state. Approximately 60 ALS subjects, at different treatment centers, already receiving nutrition from a tube in their st Brooks, Benjamin 

 

Brief Description Principal Investigator
This will be a prospective analysis of platelet function in single donor platelets using TEG-PM from the time of donation through day five - the shelf life of platelets Evans, Susan 

Ovary 

Brief Description Principal Investigator
Clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B). Crane, Erin King 

Kidney 

Brief Description Principal Investigator
The purpose of this registry is to collect information on patients who are receiving treatment with Proleukin in an organized way, and to learn more about patient care during and after treatment. Amin, Asim 

Melanoma, skin 

Brief Description Principal Investigator
The purpose of this registry is to collect information on patients who are receiving treatment with Proleukin in an organized way, and to learn more about patient care during and after treatment. Amin, Asim 

Multiple Myeloma 

Brief Description Principal Investigator
To evaluate the efficacy of NEOD001 plus standard of care vs. placebo plus standard of care when administered intravenously in subjects with AL amyloidosis by assessing time to all-cause mortality or cardiac hospitalization. Bhutani, Manisha 

Hepatitis B 

Brief Description Principal Investigator
Observational study of patients who are initiating or modifying their therapy for chronic hepatitis B. They will receive either entecavir or another standard of care HBV nucleoside/tide analogue. Russo, Mark 

Brain and Nervous System 

Brief Description Principal Investigator
This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis. Sharp, Hadley Jean 

Lip, Oral Cavity and Pharynx 

Brief Description Principal Investigator
Overall survival: From randomization to date of death or last follow-up. Moeller, Benjamin James 

Colon 

Brief Description Principal Investigator
To describe the long term safety, and clinical outcomes of aflibercept in combination with FOLFIRI in patients treated in daily practice for a metastatic CRC after failure of an oxaliplatin-based regimen. Nazemzadeh, Reza 

Rectum 

Brief Description Principal Investigator
To describe the long term safety, and clinical outcomes of aflibercept in combination with FOLFIRI in patients treated in daily practice for a metastatic CRC after failure of an oxaliplatin-based regimen. Nazemzadeh, Reza 

Soft Tissue 

Brief Description Principal Investigator
To compare the progression-free survival (PFS) of eligible subjects treated with regorafenib or placebo according to modified RECIST version 1.1. Livingston, Michael Balfour 

 

Brief Description Principal Investigator
STRATIS is a national stroke registry whose purpose is to analyze and better understand how the systems of care affect outcomes in patients who have suffered a large stroke and are treated with a neurothrombectomy device. STRATIS hopes to learn how different variables affect overall patient outcomes including actions that occur before patients arrive at the Emergency Department. This registry will enroll 1000 patients at 60 US sites. Martin, Jerry 

HIV 

Brief Description Principal Investigator
To determine the safety and efficacy of an experimental drug, abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) fixed dose combination as a single tablet regimen compared with subjects taking their current combined antiretroviral therapy (cART) for the treatment of HIV-1 infected adults in whome the HIV-1 virus is currently suppressed. Johnson, Marc 
The purpose of this study is to determine the safety and efficacy of an experimental drug, abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) fixed dose combination as a single tablet regimen compared with subjects taking their current combined antiretroviral therapy (cART) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed Johnson, Marc 

Multiple Myeloma 

Brief Description Principal Investigator
Phase I: To determine appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib and dexamethasone for patients with multiple myeloma.
Phase II: To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high risk multiple myeloma (HRMM) will improve progression-free survival (PFS). Also, to estimate the frequency and severity of toxicities of this treatment strategy in this patient population.
Usmani, Saad Zafar 

Leukemia, other 

Brief Description Principal Investigator
Primary: Evaluate antitumor activity in patients with previously treated CLL
Secondary: Evaluate addition of ublituximab to ibrutinib on complete response, minimal residual disease negativity (MRD)and effect on safety profile. This study will also evaluate progression free survival.
Ghosh, Nilanjan 

Bones and Joints 

Brief Description Principal Investigator
To describe the relationship between absolute lymphocyte count (ALC) 14 days after the start of the first cycle of chemotherapy with 2-year progression-free survival (PFS) rates and other clinical outcome measures in prospectively-treated osteosarcoma patients receiving standard treatment. Pope, Jennifer Marie 

Cytomegalovirus (CMV) 

Brief Description Principal Investigator
Gancliclovir is an IV drug that has been shown to decrease the chances of hearing loss in infants with congenitgal cytomegalovirus (CMV). Since CMV-assocaitged hearing loss often emerges after infancy, there is an unmet need for a treatment option for the toddler population. Valganciclovir is the oral form of ganciclovir and we would like to see if giving toddlers with hearing loss and congenital CMV valganciclovir for 6 weeks will stabilize hearing loss. Ahmed, Amina 

Other Hematopoietic 

Brief Description Principal Investigator
The purpose of this study is to determine if treatment with alemtuzumab, fludarabine and melphalan followed by related/unrelated bone marrow, peripheral blood stem cell, or umbilical cord blood cell transplant will result in donor engraftment on day +100. It is also to determine major toxicities from this conditioning regimen, within the first 100 days after transplantation. Gilman, Andrew Lee 
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