Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.
|Melanoma (Skin)||Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of a Vaccine Combining Tyrosinase /gp100 Peptides Emulsified With Montanide ISA 51 Alone or With a Block Co-Polymer CRL 1005 or With GM-CSF for Patients With Resected Stages IIA and IIB Melanoma Grant Application Title: MART-1/gp100 Immune Responses to a Melanoma Vaccine|
|Study Start Date:||March 1998|
|Study Completion Date:||November 2002|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF).
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003274
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|Study Chair:||Jeffrey S. Weber, MD, PhD||University of Southern California|