Carolinas HealthCare System

Research and Clinical Trials

Soft Tissue 

Brief Description PrincipalĀ Investigator
The primary objective of this study is to evaluate safety and tolerability and select a recommended Phase 2 dose (RP2D) of ADXS31-164 in subjects with solid tumors that express HER2 Tan, Antoinette Roslyn 
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 
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 Adam 
Primary Objective
To compare the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479).
Kaplan, Joel Adam 
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 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 first part of the study will determine the feasibility of adding pazopanib in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk (Non-Rhabdomyosarcoma Soft Tissue Sarcomas) NRSTS.

The second part of the study will compare the rates of response of (1) preoperative pazopanib plus chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, Grade 3 intermediate to high risk ch
Kaplan, Joel Adam 
The primary objective is to compare doxorubicin plus olaratumab versus doxorubicin plus placebo with respect to OS in patients with advanced or metastatic soft tissue sarcoma (STS) which is not amenable to treatment with surgery or radiotherapy with curative intent. Kim, Edward Sanghyun 
Primary Objectives and Endpoints
1.1.1 To evaluate the safety and tolerability of ODSH in pediatric patients receiving ?ICE? (Ifosfamide mixed with Mesna, Carboplatin and Etoposide) chemotherapy.

1.1.2 To evaluate preliminary evidence of an effect of ODSH on time to platelet recovery, defined as when the platelet count remained > 100,000 after nadir for two consecutive days in the absence of a prior platelet transfusion within the previous 48 hours in pediatric patients receiving ?ICE? c
Oesterheld, Javier E 
To compare the progression-free survival (PFS) of eligible subjects treated with regorafenib or placebo according to modified RECIST version 1.1. Livingston, Michael Balfour 
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