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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077532 |
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma.
PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: gp100 antigen Drug: incomplete Freund's adjuvant Drug: ipilimumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 in the Treatment of Patients With Stage IV Melanoma |
Estimated Enrollment: | 179 |
Study Start Date: | March 2004 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
No history of any of the following:
No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage
No systemic hypersensitivity to study agents
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000352187, NCI-04-C-0083, MDX-010-19, NCI-6532 |
Study First Received: | February 10, 2004 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00077532 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Freund's Adjuvant Nevus Recurrence Immunoglobulins Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Adjuvants, Immunologic Nevi and Melanomas Pharmacologic Actions |