Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor (PNET) (REMATCH)
This study will have two phases. During Phase I, the investigators will treat patients with increasing doses of the tumor-specific immune cells that the investigators have expanded in the investigators clinical laboratory to establish the safety of this treatment regimen. These patients will also receive dendritic cell vaccines to help boost the function of these immune cells and maintain their growth after being returned to the patient. The investigators expect to treat approximately 9 patients during the Phase I component to establish that this treatment seems safe. In the Phase II component, once the treatment has been shown to be safe, the investigators will treat a larger number of patients (approximately 35) with expanded tumor-specific immune cells and dendritic cell vaccines and evaluate the impact on tumor growth in these patients. This will allow us to determine whether tumor growth is prevented or delayed compared to patients that have received similar treatment without immunotherapy. This type of comparison to previously treated patients (called historical control comparison) will allow us to determine whether this treatment regimen looks promising enough to evaluate in larger clinical trials to definitively establish the effectiveness of this approach.
Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers, and the investigators hope to use the experience the investigators have gained in the immunologic treatment of adult patients with malignant brain tumors at the investigators center to improve the clinical outcome for children affected by this disease. This study has significant potential to impact the families of civilians and military dependents, as the brain is the most frequent site of crippling injuries in humans and unfortunately, brain cancer is currently the leading cause of cancer deaths in children in the United States.
Biological: TTRNA-xALT with TTRNA-DCs
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy During Recover From Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation|
- Establishing the safety of DC + xALT therapy in this patient population with total tumor RNA (TTRNA)-xALT and TTRNA-DCs will be the primary goal in the Phase I portion of the trial. [ Time Frame: 44 months ] [ Designated as safety issue: Yes ]Number of participants with adverse events as a measure of safety and tolerability.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: TTRNA-xALT with TTRNA-DC
An escalating total dose of TTRNA-xALT (3 x 10^6/Kg, 3 x 10^7/Kg, and 3 x 10^8/Kg) with TTRNA-DCs (2 x 10^7) will be evaluated in separate cohorts of 3 to 6 patients each for the purpose of establishing a maximally tolerated dose (MTD) and a dose-limiting toxicity (DLT) in this patient population.
Biological: TTRNA-xALT with TTRNA-DCs
An escalating total dose of TTRNA-xALT (3 x 106/Kg, 3 x 107/Kg, and 3 x 108/Kg) with TTRNA-DCs (2 x 107) will be evaluated in separate cohorts of 3 to 6 patients each for the purpose of establishing a maximally tolerated dose (MTD) and a dose-limiting toxicity (DLT) in this patient population.
Show Detailed Description
|Contact: Jennifer F King, RNfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Denise Lally-Goss 919-684-3862|
|Principal Investigator: Duane Mitchell|
|Principal Investigator:||Duane A Mitchell, M.D., Ph.D.||Duke University|