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Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma

NCT00118313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-03-27

No results posted yet for this study

Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with imiquimod after surgery may help the body kill any remaining tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best way to give vaccine therapy with or without imiquimod in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

multi-epitope melanoma peptide vaccine

BIOLOGICAL

sargramostim

BIOLOGICAL

tetanus toxoid helper peptide

DRUG

dimethyl sulfoxide

DRUG

imiquimod

PROCEDURE

adjuvant therapy

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

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
12 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-04
Primary Completion
2006-07-28
Completion
2006-07-28

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 NCT00118313 on ClinicalTrials.gov