Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor
|ClinicalTrials.gov Identifier: NCT00069940|
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : December 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Gastrointestinal Stromal Tumor Sarcoma||Biological: sargramostim Biological: telomerase: 540-548 peptide vaccine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|