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

NCT00077532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2012-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

gp100 antigen

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

ipilimumab

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Steven A. Rosenberg, MD, PhD · NCI - Surgery Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-01-31
Completion
2008-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00077532 on ClinicalTrials.gov