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Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma

NCT00357461 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-05-15

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma.

PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

gp100:209-217(210M) peptide vaccine

BIOLOGICAL

gp100:280-288(288V) peptide vaccine

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

ipilimumab

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31

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Drugs
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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 NCT00357461 on ClinicalTrials.gov