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Novel Adjuvants for Peptide-Based Melanoma Vaccines
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Condition | Treatment or Intervention | Phase |
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Melanoma |
Vaccine: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine |
Phase I Phase II |
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open Label Study of MDX-CTLA4 in Combination with Tyrosinase/gp100/MART-1 Peptides Emulsified with Montanide ISA 51 in the Treatment of Patients with Resected Stage III or IV Melanoma
Expected Total Enrollment: 72
Study start: July 2001;
Study completion: June 2004
In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
Exclusion criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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