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. Huo, Jeffrey
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
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 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: 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 report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia at one and two-years following allogeneic HCT for hematologic malignancy. Huo, Jeffrey
1. To determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with venous thromboembolism (VTE), and with or without cancer, using anti-Xa (Xa) levels and a population PD analysis methodology

2. To determine the median dose (IU/kg) required to achieve therapeutic anti-Xa levels (0.5 to 1.0 International Units[IU]/mL) based on subject age and weight.
Hinson, Ashley Rebekah Presar