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
PRIMARY OBJECTIVES:
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
toxicity.
Patients are followed at 2-4 weeks, every 6 months for 3 years, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study within 1 year.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Immune response
Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).
Baseline
No
Jeffrey Weber
Principal Investigator
University of Southern California
United States: Food and Drug Administration
NCI-2012-02618
NCT00089063
June 2004
Name | Location |
---|---|
University of Southern California | Los Angeles, California 90033 |