NCT00072085

Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	gp100 antigen
BIOLOGICAL	incomplete Freund's adjuvant

Timeline

• Start date: 2003-09-01
• Completion: 2006-07-01
• First posted: 2003-11-06
• Last updated: 2013-06-19

Locations

2 sites across 1 country: United States