Carolinas HealthCare System

Research and Clinical Trials

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
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
Primary: To compare overall survival (OS) of subjects with newly-diagnosed MGMT-methylated, partially methylated, or intermediate GBM treated with RT plus TMZ combined with nivolumumab or placebo.
Secondary: To compare progression-free survival (PFS) of subjects with newly-diagnosed MGMT-methylated, partially methylated, or indeterminate GBM treated with RT plus TMZ with nivolumab or placebo.
Sumrall, Ashley Love
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
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
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
To determine the safety and tolerability of tolcapone alone and in combination with oxaliplatin at 4 dose levels of tolcapone in subjects with relapsed or refractory neuroblastoma Oesterheld, Javier E
To determine the feasibility of identifying a targeted agent by molecular methods and incorporating that agent into standard upfront high risk neuroblastoma treatment in cycles 3-6 of induction. Following standard consolidation therapy with autologous stem cell transplant (ASCT), radiotherapy (XRT) (if indicated) and standard maintenance therapy with Ch14:18 antibody and cis retinoic acid, the feasibility of adding further maintenance therapy with DFMO will also be assessed. Oesterheld, Javier E
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
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
Phase 2b: Determine if the addition of ABT414 to concomitant radiotherapy and temozolomide prolongs progression free survival (PFS) among subjects with newly diagnosed GBM harboring EGFR amplification.
Phase 3: To determine if addition of ABT414 to concomitant radiotherapy and temozolimide plus adjuvant temozolomide prolongs Overall Survival (OS) among subjects with newly diagnosed GBM harboring EGFR amplification.
Sumrall, Ashley Love