NCT00089063

Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma

A Randomized Phase II Continuation Booster Trial After A Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 and ISA 51 VG With Or Without GM-CSF For Patients With Resected Stages IIB/C, III And IV Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides 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 make a stronger immune response.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate immune reactivity to a tyrosinase:368-376 (370D) /gp100: 209-217 (210M)/MART-1 26-35 (27L) peptide vaccine with Montanide ISA 51 with or without GM-CSF administered as a booster for five vaccinations over two years. OUTLINE: This is a randomized, parallel, continuation study. Patients are stratified according to response to prior vaccination (response to 1 peptide vs response to 2 or more peptides). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG subcutaneously (SC) on day 1 of weeks 0, 26, 52, 78, and 104 (total of 5 vaccinations). Arm II: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I. Patients also receive sargramostim (GM-CSF) SC on days 1-5 of weeks 0, 26, 52, 78, and 104. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 2-4 weeks, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study within 1 year.

Conditions

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Extraocular Extension Melanoma
• Iris Melanoma
• Stage IIB Melanoma
• Stage IIC Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	tyrosinase peptide	Given SC
BIOLOGICAL	gp100 antigen	Given SC
BIOLOGICAL	MART-1 antigen	Given SC
BIOLOGICAL	incomplete Freund's adjuvant	Given SC
DRUG	Montanide ISA 51 VG	Given SC
BIOLOGICAL	sargramostim	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-06-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2004-08-05
• Last updated: 2015-04-15

Locations

1 site across 1 country: United States