Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institutes of Health Clinical Center (CC)
Study ID
NCT00077532
Phase
PHASE2
Status
Completed

Conditions

  • Melanoma (Skin)

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • gp100 antigen — BIOLOGICAL
  • incomplete Freund's adjuvant — BIOLOGICAL
  • ipilimumab — BIOLOGICAL

Study Details

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.

Key Dates

Start date
Mar 31, 2004
Status verified
Jun 2012
Primary completion
Jan 31, 2007
Completion
Feb 29, 2008

Study Design

Enrollment
179 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Objective response (partial and complete)

Locations (1)

FacilityCityStateZIPSite coordinators
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesdaMaryland20892-1182-

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By research site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support· Bethesda, MD

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