A Randomized Phase II Continuation Booster Trial After A Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 and ISA 51 VG With Or Without GM-CSF For Patients With Resected Stages IIB/C, III And IV Melanoma
I. To evaluate immune reactivity to a tyrosinase:368-376 (370D) /gp100: 209-217
(210M)/MART-1 26-35 (27L) peptide vaccine with Montanide ISA 51 with or without GM-CSF
administered as a booster for five vaccinations over two years.
OUTLINE: This is a randomized, parallel, continuation study. Patients are stratified
according to response to prior vaccination (response to 1 peptide vs response to 2 or more
peptides). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1
antigen emulsified with Montanide ISA-51 and ISA-51 VG subcutaneously (SC) on day 1 of weeks
0, 26, 52, 78, and 104 (total of 5 vaccinations).
Arm II: Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and
MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I. Patients also
receive sargramostim (GM-CSF) SC on days 1-5 of weeks 0, 26, 52, 78, and 104.
In both arms, treatment continues in the absence of disease progression or unacceptable
Patients are followed at 2-4 weeks, every 6 months for 3 years, and then annually
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study within 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
University of Southern California
United States: Food and Drug Administration
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