Carolinas HealthCare System

Research and Clinical Trials

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 
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 
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 
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 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 
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