Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor.
Brain and Central Nervous System Tumors
Gastrointestinal Stromal Tumor
Biological: telomerase: 540-548 peptide vaccine
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF|
|Study Start Date:||December 2000|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and sargramostim (GM-CSF) in patients with sarcoma or brain tumor.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients.
- Determine, preliminarily, the clinical response, if any, of patients treated with this regimen.
OUTLINE: Patients receive telomerase: 540-548 peptide vaccine subcutaneously (SC) on day 3 and sargramostim (GM-CSF) SC on days 1-4 of weeks 1, 3, 5, 7, 9, 11, 15, 19, and 23.
PROJECTED ACCRUAL: A total of 35 patients (20 adult and 15 pediatric) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069940
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||W. Nicholas Haining, BM, BCh||Dana-Farber Cancer Institute|