Carolinas HealthCare System

Research and Clinical Trials

Major Depressive Disorder 

Brief Description Principal Investigator
The purpose of this study is to assess the maintenance of efficacy of LY2216684 compared with placebo as add on therapy to SSRI among patients with Major Depressive Disorder and patients with partial response to SSRI treatment that met the remission criterion with add on LY2216684 during open-label treatment. Tcheremissine, Oleg 

Liver injury-drug induced 

Brief Description Principal Investigator
An observational study and registry for subjects who have experienced liver injury due to drugs or herbal remedies or nutritional supplements. Bonkovsky, Herbert 

ALS - Amyotrophic Lateral Sclerosis 

Brief Description Principal Investigator
The primary objective is to identify factors that contribute to the pathogenesis of amyotrophic lateral sclerosis (ALS). Development of disease biomarkers and diagnostic laboratory tests would facilitate earlier treatment intervention, help monitor treatment efficacy; and, ultimately, lead to the identification of targets that could be used in therapy development. Specific aim 2 is to assess how biomarkers discovered in aim 1 change with disease course. Blood samples will be collected longit Brooks, Benjamin 

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 
To investigate the safety and tolerability of AZD9291 when given orally to patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following prior therapy with an Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) agent. Secondary objectives include defining the maximum tolerated dose or maximum feasible dose of AZD9291; to investigate the safety and tolerability of AZD9291 when given orally as first line therapy to patients who Haggstrom, Daniel 

Melanoma, skin 

Brief Description Principal Investigator
The objective is to compare the efficacy and safety of masitinib at 7.5 mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit (c-kit JM). Amin, Asim 

Corpus Uteri 

Brief Description Principal Investigator
Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy. Tait, David 

Breast - Female 

Brief Description Principal Investigator
This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer White, Richard L 

Bladder 

Brief Description Principal Investigator
The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and gemcitabine or ALT-801 in combination with gemcitabine alone. Mahoney, John 
The purpose of this study is to confirm the safety and tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in treated patients. The anti-tumor responses will also be assessed. Mahoney, John 

 

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 

Kidney 

Brief Description Principal Investigator
To compare overall survival (OS) between study arms in subjects treated with AGS-003 in combination with standard treatment (combination arm) versus active control of standard treatment alone (control arm) Amin, Asim 

 

Brief Description Principal Investigator
Examine the nausea reduction of aromatherapy using a tested blend of essential oils compared to normal saline. Examine the longevity of the reduction of nausea from aromatherapy using a tested blend of essential oils. Examine the perception of comfort from using a nasal clip to deliver the aromatherapy. Inclusion criteria includes age 18 or over, not allergic to peppermint, spearmine, ginger or cardomom, not receiving blood thinning medications. Hunt, Ronald 

Multiple Myeloma 

Brief Description Principal Investigator
This multicenter Phase 2 study is designed to assess the efficacy and safety of ARRY-520 in approximately 160 patients with multiple myeloma who have received at least 2 prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide Usmani, Saad 
Estimate the progression-free survival (PFS) of patients treated with carfilzomib + ARRY-520 and of patients treated with single-agent carfilomib. Usmani, Saad 

Kidney 

Brief Description Principal Investigator
The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma. Amin, Asim 

Colon 

Brief Description Principal Investigator
This trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. Salmon, Stuart 

Esophagus 

Brief Description Principal Investigator
This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy. Salo, Jonathan 

Soft Tissue 

Brief Description Principal Investigator
Describe the sensitivity of flow cytometry to detect tumor cells in the
blood and bone marrow of Ewing sarcoma patients, using FISH as a goldstandard comparison to confirm the presence of tumor cells.
Oesterheld, Javier 

Breast - Female 

Brief Description Principal Investigator
Celera Corporation: Comparison of Breast Cancer Somatic Gene Expression Measurements for Potential O Calhoun, Ben 

DMD - Muscular Dystrophies 

Brief Description Principal Investigator
The study will help determine if CoQ10 or lisinopril improve the decline in cardiac muscle function that occurs in muscular dystrophies. Study Details: The study is a multicenter study being conducted through the Cooperative International Neuromuscular Research Group (CINRG) and will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no clinical cardiac symptoms. Participants will Sparks, Susan 

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 

Lymphoid Leukemia 

Brief Description Principal Investigator
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Kaplan, Joel 
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 
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 
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 
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 

Myeloid and Monocytic Leukemia 

Brief Description Principal Investigator
This randomized phase II/III trial is studying how well giving bortezomib and sorafenib tosylate together works in treating patients with newly diagnosed acute myeloid leukemia with or without mutations Kaplan, Joel 

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 

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 

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 
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 
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 
This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors. Kaplan, Joel 

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 
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma. Kaplan, Joel 

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 

Hodgkin's Lymphoma 

Brief Description Principal Investigator
The purpose of this study is to establish a biologic specimen repository (of tumor tissue, tissue arrays, lymphoblastoid cell lines, host DNA, tumor and host RNA, serum, and plasma) and database linked to clinical features and outcomes from well-characterized cohorts of children and young adults with Hodgkin's lymphoma. Kaplan, Joel 

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 

Soft Tissue 

Brief Description Principal Investigator
COG ANBL0032: Phase III Randomized Study of Chimeric antibody 14.18 (Ch 14.18) in High Risk Neurobl Kaplan, Joel 
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 

Ill-Defined Sites 

Brief Description Principal Investigator
To identify whether temsirolimus or ch14.18 (monoclonal antibody Ch14.18) is the optimal therapeutic agent to consider for further testing in a future Phase III randomized trial for treatment of newly diagnosed high-risk neuroblastoma. Kaplan, Joel 

Leukemia, other 

Brief Description Principal Investigator
The purpose of this study for the patients with advanced stage B-cell NHL/B-AL is to test whether adding 6 injections of rituximab to standard LMB chemotherapy regimen, improves the EFS compared with LMB chemotherapy alone. Kaplan, Joel 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
The purpose of this study for the patients with advanced stage B-cell NHL/B-AL is to test whether adding 6 injections of rituximab to standard LMB chemotherapy regimen, improves the EFS compared with LMB chemotherapy alone. Kaplan, Joel 

Ill-Defined Sites 

Brief Description Principal Investigator
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 

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 

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 
This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Kaplan, Joel 

 

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 

Melanoma, skin 

Brief Description Principal Investigator
This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery. Amin, Asim 

Kidney 

Brief Description Principal Investigator
To determine if DASL subclassification can identify a group of patients with advanced
melanoma who are significantly more likely to respond to high dose IL-2-based therapy
(Class 2) than the historical 16% response rate in an unselected patient population.
Amin, Asim 

ALS - Amyotrophic Lateral Sclerosis 

Brief Description Principal Investigator
The purpose is to determine if the NeuRx(R) Diaphragm Pacing SystemTM (DPS) for people with ALS and hypoventilation is associated with improved survival or diaphragm function. Subjects will be randomly assigned in a 2:1 ratio to DPSX or standard of care (control) treatment. The DPS group will have the DPS device surgically implanted. Subjects will remain on DPS or standard of care treatment for the duration of the study (12-36 months). Brooks, Benjamin 

HIV 

Brief Description Principal Investigator
The purpose of this study is to evaluate the experimental drug elvitegravir which is one of a new class of anti-HIV medications called integrase inhibitors. The study will attempt to determine if elvitegravir is safe and effective when given in combination with the background regimen (the other antiviral medications that a patient may currently be taking or will take to participate in the study), in subjects who are failing their current regimen of HIV medications. Johnson, Marc 
Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) active against HIV-1 with demonstrated potency in treatment-experienced patients and potent short-term activity in treatment naïve patients reducing plasma HIV RNA. To date, etravirine has not been evaluated as part of combination antiretroviral therapy for naive patients initiating treatment for HIV infection. Johnson, Marc 

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 

Liver 

Brief Description Principal Investigator
A research study of a new fibrin sealant, product named FS Grifols used during scheduled liver surgery. This product will be applied during liver surgery to liver tissue with moderate (gradual and steady) bleeding with the purpose of learning about its safety and efficacy in reducing time to haemostatis (cessation of bleeding) as compared to Surgicel(R) (an approved product to make the blood clot and shorten the bleeding time). Iannitti, David 

Colon 

Brief Description Principal Investigator
To compare the effectiveness of treatment with SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone in terms of overall survival.



Frenette, Gary 

Liver 

Brief Description Principal Investigator
To compare the effectiveness of treatment with SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone in terms of overall survival.



Frenette, Gary 

Other Hematopoietic 

Brief Description Principal Investigator
Complete response of VOD [ Time Frame: D+100 from SCT or 100 days from start of chemotherapy] Gilman, Andrew 

HIV 

Brief Description Principal Investigator
The purpose of this study is to see if the combination pill FTC/RPV/TDF is safe and effective in reducing levels of HIV-1 in the blood of subjects who are treatment-naïve (those who have not received any antiretroviral medication).The safety and effectiveness of FTC/RPV/TDF will be compared with that of Atripla®, a combination medication containing efavirenz, FTC, and TDF. Atripla® has been approved by the FDA for the treatment of HIV. An approved dose of Atripla® is being used in this study. Johnson, Marc 
This trial is looking at the safety, tolerability and effectiveness of a medication named cobisitat in HIV postitive individuals. Both naïve (never been on therapy) and treatment experienced patients are being considered. This trial will be looking at the effectiveness of the combination of Darunavir with cobisistat with an investigator defined backbone. The duration of this trial is at least 48 weeks or approximately one year. Johnson, Marc 

Ovary 

Brief Description Principal Investigator
This randomized phase III trial is studying giving carboplatin, paclitaxel and gemcitabine together with or without bevacizumab after surgery to see how well it works in treating patients with recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer. Higgins, Robert 
This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival of patients with previously treated stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Higgins, Robert 

Corpus Uteri 

Brief Description Principal Investigator
This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer. Higgins, Robert 

Cervix Uteri 

Brief Description Principal Investigator
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Higgins, Robert 

Corpus Uteri 

Brief Description Principal Investigator
This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with stage III, IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Metformin hydrochloride may help paclitaxel and carboplatin work better by Higgins, Robert 

Other Female Genital 

Brief Description Principal Investigator
Primary: Estimate progression free survival hazard ration and determing frequency and severity of adverse events associated with the treatment of weekly paclitaxel vs. weekly paclitaxel and REOLYSIN® treatment. Miller, Brigitte 

Ovary 

Brief Description Principal Investigator
Primary: Estimate progression free survival hazard ration and determing frequency and severity of adverse events associated with the treatment of weekly paclitaxel vs. weekly paclitaxel and REOLYSIN® treatment. Miller, Brigitte 
To determine the efficacy of olaparib compared to placebo by progression free survivalin BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. Higgins, Robert 

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 

 

Brief Description Principal Investigator
Pregnant women who have no visible signs of herpes simplex virus (HSV), admitted to hospital in active labor. We are testing use of new laboratory device called Xpert to see if it can determine if a woman is shedding (getting rid of) HSV. We will compare the results of the new device to the currently approved laboratory tests. It is important for an OB/Gyn to know the HSV status of women in labor because HSV is often passed to babies during delivery. Ahmed, Amina 

HIV 

Brief Description Principal Investigator
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of the combination of etravirine 400mg with darunavir/ritonavir 800/100mg, all given once a day. In addition, this study will compare changes in cholesterol and blood sugar, along with changes in body fat, bone density, and markers of inflammation and immune function from Baseline (Day 1) to Week 48. Finally, the study will also assess the levels of these drugs in the body. Johnson, Marc 

Lung 

Brief Description Principal Investigator
The purpose of this specimen banking study is to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multi-protein classifier based on the observed prevalence of Non-Small Cell Lung Cancer, for patients with a lung nodule between 8 mm to 20 mm in size, except for those characterized as "pure ground glass opacity" or "non-solid." Mileham, Kathryn 

Non-Hodgkin's Lymphoma 

Brief Description Principal Investigator
The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL). Ghosh, Nilanjan 

Liver tumors 

Brief Description Principal Investigator
This is a data collection study of clinical information from patients who have undergone bead treatment for unresectable tumors of the liver. Iannitti, David 

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 

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 

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 

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 
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 

Breast - Female 

Brief Description Principal Investigator
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex. White, Richard L 
Primary: To assess breast health knowledge among Latino women who have attended a "Living Room Visit" breast education program by comparing pre and post-interventional surveys administered to women immediately before and after education and three months after intervention.
Secondary: To evaluate patterns of survey responses and explore quantitatively the overall feasibility of the community assessment program in terms of completion rate of the 3 month follow-up survey.
Carrizosa, Daniel 

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, Stuart 

Bladder 

Brief Description Principal Investigator
Primary: To characterize primary tumor co-expression of aurora kinase A (AK-A) and aurora kinase B (AK-B) in patients with muscle-invasive bladder cancer (MIBC) and correlate with clinicopathologic outcome following neoadjuvant chemotherapy (NAC).
Secondary: To measure circulating tumor cell (CTC) levels and CTC AK-A and AK-B expression and correlate with clinicopathologic outcome following NAC.
Burgess, Earle 

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 

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 

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 

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 

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 

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 

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 

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 

Lung 

Brief Description Principal Investigator
To evaluate the overall response rate (ORR) of LY2875358 plus Erlotinib Therapy and LY2875358 monotherapy in Patients with Met Proto-Oncogene (hepatocyte growth factor receptor)(MET) diagnostic positive (MET diagnostic (+)) non-small cell lung cancer (NSCLC) and acquired resistance to erlotinib. Mileham, Kathryn 

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
This trial is studying how well hormone therapy or chemotherapy before surgery based on gene expression analysis works in treating patients with breast cancer. Limentani, Steven A 

Melanoma, skin 

Brief Description Principal Investigator
This is an expanded access program (EAP) for participants who have progressed after prior systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated. Participants cannot be eligible for or have participated in any MK-3475 clinical trial. Amin, Asim 

Other Hematopoietic 

Brief Description Principal Investigator
The objective of this treatment protocol is to allow pediatric patients who have failed to respond to steroid treatment for acute GVHD expanded access to Prochymal. Gilman, Andrew 

Lung 

Brief Description Principal Investigator
To compare the overall survival (OS) of previously treated patients with SCC NSCLC treated with MK-3475 compared to docetaxel. Carrizosa, Daniel 

Hepatitis C 

Brief Description Principal Investigator
Evaluate the effectiveness of MK-5172 in combination with MK-8742 in treating subjects with chronic hepatitis C virus (HCV) infection with chronic kidney disease Zamor, Philippe 

Ill-Defined Sites 

Brief Description Principal Investigator
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 

Soft Tissue 

Brief Description Principal Investigator
To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event Free Survival (EFS). Oesterheld, Javier 

Breast - Female 

Brief Description Principal Investigator
The primary aim of this Phase III randomized clinical trial is to determine whether trastuzumab given concurrently with radiation therapy (RT) is more beneficial in preventing subsequent ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral DCIS, when compared with RT alone in women with HER2-positive ductal carcinoma in situ (DCIS) resected by lumpectomy.
Limentani, Steven A 
To determine whether the addition of trastuzumab to chemotherapy (TC or AC?_WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed. Limentani, Steven A 
NSABP B-50-I: A randomized, multicenter, open-label phase III study to evaluate the eff Limentani, Steven A 
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 

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 

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 

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 

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 

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 

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 

Prostate 

Brief Description Principal Investigator
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
Mahoney, John 

Lymphoid Leukemia 

Brief Description Principal Investigator
To compare the hematological remission, defined as CR (both CR and CRi), reported by the external independent adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive the active comparator (Arm B). Grunwald, Michael 

Multiple Myeloma 

Brief Description Principal Investigator
Phase I: to determine the maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of ibrutinib in combination with carfilzomib; and to describe the toxicities associated with the combination of ibrutinib and carfilzomib in subjects with relapsed or relapsed and refractory multiple myeloma (MM). Usmani, Saad 
Phase 1b: To determine the maximum tolerated dose and identify the recommended Phase 3 dose of oprozomib in combination with pomalidomide and dexamethasone.
Phase 3: To compare progression-free survival between subjects treated with OPomD versus those treated with PomD.
Usmani, Saad 

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 

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 

HIV 

Brief Description Principal Investigator
With an estimated 33.2 million people in the world infected with the virus, human immunodeficiency virus (HIV) is a major medical problem.

The purpose of this study is to see if the investigational compound of elvitegravir/emtricitabine/tenofovir/cobicistat (EVG/FTC/TDF/GS-9350) is safe and effective in reducing levels of HIV in the blood of subjects who are treatment-naïve (those who have not received any antiretroviral medication).
Johnson, Marc 
With an estimated 33.2 million people in the world infected with the virus, human immunodeficiency virus (HIV) is a major medical problem.

The purpose of this study is to see if the investigational compound of elvitegravir/emtricitabine/tenofovir/cobicistat (EVG/FTC/TDF/GS-9350) is safe and effective in reducing levels of HIV in the blood of subjects who are treatment-naïve (those who have not received any antiretroviral medication).
Johnson, Marc 

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 

Breast - Female 

Brief Description Principal Investigator
To compare invasive disease-free survival (DFS) in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer randomized to either chemotherapy plus 1 year of trastuzumab plus pertuzumab or chemotherapy plus 1 year of trastuzumab emtansine plus pertuzumab. Fisher, Julie 

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 
This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Sumrall, Ashley 

Esophagus 

Brief Description Principal Investigator
This randomized phase III trial is studying how well giving radiation therapy, paclitaxel, and carboplatin together with or without trastuzumab works in treating patients with esophageal cancer. Salo, Jonathan 

Lip, Oral Cavity and Pharynx 

Brief Description Principal Investigator
This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer. Crimaldi, Anthony 

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 

HIV 

Brief Description Principal Investigator
With an estimated 33.2 million people in the world infected with the virus, human immunodeficiency virus (HIV) is a major medical problem.

The purpose of this study is to evaluate the safety of a new medication (GSK1349572) in HIV infected individuals who have never taken antiretroviral medications before. This study is also comparing the efficacy of GSK1349572 + epzicom to Atripla which is currently one of the medications used for HIV therapy.
Johnson, Marc 

Kidney 

Brief Description Principal Investigator
Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery. Amin, Asim 

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 

Prostate 

Brief Description Principal Investigator
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide. Burgess, Earle 

Lymphoid Leukemia 

Brief Description Principal Investigator
Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.


Oesterheld, Javier 

Ill-Defined Sites 

Brief Description Principal Investigator
The goal of the Phase I study is to find out the dose of panobinostat that can be safely given to children with relapsed ALL, AML, HD and NHL. Oesterheld, Javier 

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 
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