A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma
- Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV
melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with
Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are stratified according to disease stage
(cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are
randomized to 1 of 3 treatment arms.
- Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217
(210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose
interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1,
3, 5, 7, 11, 15, 19, 27, and 53.
- Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC,
and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
- Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose
IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27,
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this
study within 3 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 and Hospital||Los Angeles, California 90033-0804|