Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
FDA Office of Orphan Products Development |
---|---|
Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00028431 |
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 | Intervention | Phase |
---|---|---|
Melanoma |
Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine |
Phase I Phase II |
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 |
Estimated Enrollment: | 72 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, California | |
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90089 | |
Contact: Jeffrey S Weber, M.D., Ph.D. 323-865-3919 jweber@hsc.usc.edu |
Principal Investigator: | Jeffrey S. Weber, M.D., Ph.D. | University of Southern California/Norris Cancer Center |
Study ID Numbers: | FD-R-1975-01, 10M-00-4;, FD-R-001975-01 |
Study First Received: | January 4, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00028431 |
Health Authority: | United States: Food and Drug Administration |
Stage III melanoma Stage IV melanoma Interleukin-12 Cancer Vaccines Antineoplastic Agents, Combined Incomplete Freund's adjuvant Monophenol Monooxygenase |
Mannitol Adjuvants, Immunologic Melan-A Protein Antigens, Neoplasm Antibodies Melanocyte lineage-specific antigen gp100 CTLA-4 |
Interleukin-12 Cytotoxic T-lymphocyte antigen 4 Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Antibodies Mannitol |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Freund's Adjuvant Nevus Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions |