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Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

NCT00089193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-23

No results posted yet for this study

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients with stage II B, stage IIC, stage III, or stage IV melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

multi-epitope melanoma peptide vaccine

BIOLOGICAL

sargramostim

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Craig L Slingluff, Jr

    lead OTHER

Principal Investigators

  • Craig L. Slingluff, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-02-28

Countries

  • United States

Study Locations

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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 NCT00089193 on ClinicalTrials.gov