A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma
OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with
Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in
HLA-A2 positive patients with stage III or IV melanoma.
OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy
(immunotherapy or chemotherapy vs surgery only). Patients are randomized to receive 1 of 2
treatment arms: Arm I: Following surgery, patients receive tyrosinase and gp100 peptides
emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2,
4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Arm II: Following surgery, patients
receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2,
4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Patients are followed at 2-4 weeks,
then every 3 months for 2 years after resection, then every 6 months for 3 years, and then
yearly if without evidence of disease.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Jeffrey S. Weber, MD, PhD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|Beckman Research Institute, City of Hope||Los Angeles, California 91010|