Spots Global Cancer Trial Database for Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor

Official Title: A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Study ID: NCT00069940

Conditions

Brain and Central Nervous System Tumors

Gastrointestinal Stromal Tumor

Sarcoma

Interventions

sargramostim

telomerase: 540-548 peptide vaccine

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.