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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
Study Chair
USC/Norris Comprehensive Cancer Center
United States: Federal Government
CDR0000066176 (10M-97-1)
NCT00003274
March 1998
November 2002
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |