Spots Global Cancer Trial Database for Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

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Trial Identification

Brief Title: Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma

Official Title: A Pilot Study of NY-ESO-1 Immunization in Patients With NY-ESO-1/LAGE Antigen Expressing Cancer

Study ID: NCT00027911

Conditions

Sarcoma

Interventions

NY-ESO-1 peptide vaccine

sargramostim

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 be effective in treating soft tissue sarcoma. PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with sargramostim in treating patients who have stage II, stage III, or stage IV soft tissue sarcoma.

Detailed Description: OBJECTIVES: * Determine the safety and tolerability of NY-ESO-1 peptide vaccine and sargramostim (GM-CSF) in patients with stage II, III, or IV soft tissue sarcoma expressing NY-ESO-1 or LAGE antigen. * Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) in patients treated with this regimen. * Determine tumor responses in patients treated with this regimen. OUTLINE: Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) subcutaneously once daily beginning 2 days before every vaccination and continuing for 5 days. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12 months.