Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
The primary objective of this intermediate-size, expanded access protocol is to provide patients with serious adenovirus infection or disease access to treatment with Brincidofovir. Eckrich, Michael James
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
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
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 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
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
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
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
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
This study will examine how effective pazopanib is for treating children with a variety of relapsed solid tumors.

It will also seek to further define the toxicities of pazopanib in children, as well as examine biologic markers that may help to further define the response characteristics of pazopanib.
Kaplan, Joel Adam
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
To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia at one and two-years following allogeneic HCT for hematologic malignancy. Eckrich, Michael James
The primary objective of this study is to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy. Oesterheld, Javier E
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