Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00077532|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : June 22, 2012
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 or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||179 participants|
|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|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||February 2008|
- Objective response (partial and complete)
- Immune response activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077532
|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|