Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants
OBJECTIVES: I. Evaluate the immunogenicity of gp100-tyrosinase peptide vaccine with
sargramostim (GM-CSF), Montanide ISA-51, or QS21 as adjuvant in patients with advanced
melanoma. II. Determine the toxicity of this multiepitope melanoma peptide vaccine in
conjunction with these 3 adjuvants in these patients. III. Evaluate the antitumor effects of
this multiepitope melanoma peptide vaccine in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to age (65 years and
under vs more than 65 years) and previous systemic chemotherapy (yes vs no). Patients are
randomized to 1 of 3 treatment arms: Arm I (Sargramostim (GM-CSF) as adjuvant): Patients
receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered
intradermally during weeks 1, 5, and 9. For each vaccination, GM-CSF is administered
intradermally on days 1-10; the vaccine is administered on day 7. Arm II (Montanide ISA-51):
Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with
Montanide ISA-51 and administered subcutaneously (SQ) during weeks 1, 5, and 9. Arm III
(QS21 as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide
vaccine mixed with QS21 and administered SQ during weeks 1, 5, and 9. Patients with stable
or responding disease may receive 3 additional monthly immunizations beginning 3-6 months
following completion of 1 course of immunizations if there is evidence of T cell response
against either wild type peptide. Patients are followed at weeks 13 and 17.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 18-24
months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Paul B. Chapman, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
98-012
NCT00003362
May 1998
February 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |