Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00072085
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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 arms.
* Cohort 1 (HLA-A2\*0201-positive patients): Patients are randomized to 1 of 2 treatment arms.
* 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 course).
* 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, arm I.
In both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
NCI - Center for Cancer Research
🇺🇸Bethesda, Maryland, United States