Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen
- Compare the clinical response in patients with metastatic melanoma immunized with
recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without
gp100:209-217 (210M) peptide.
- Compare the toxicity profile of these immunizations in these patients.
OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to
HLA-A2*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment
- Cohort 1 (HLA-A2*0201-positive patients): Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive immunization comprising recombinant gp100 protein (184V)
emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1
- Arm II: Patients receive immunization comprising recombinant gp100 protein (184V)
and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22,
43, and 64 (1 course).
- Cohort 2 (HLA-A2*0201-negative patients): Patients receive immunization as in cohort 1,
In both cohorts, treatment continues in the absence of rapid disease progression or
In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients
achieving stable disease or a partial response receive retreatment according to their
assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2)
receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes
3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3
retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment
course beyond CR. Patients with progressive disease who are ineligible for IL-2
administration are removed from the study.
PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 [15-25 per treatment arm]
and 15-25 for cohort 2) will be accrued for this study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|