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Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

NCT00031733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-05-22

No results posted yet for this study

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Conditions

  • Intraocular Melanoma
  • Melanoma (Skin)

Interventions

BIOLOGICAL

MART-1 antigen

BIOLOGICAL

gp100 antigen

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

recombinant interleukin-12

BIOLOGICAL

sargramostim

BIOLOGICAL

tyrosinase peptide

DRUG

alum adjuvant

PROCEDURE

adjuvant therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Jeffrey S. Weber, MD, PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2004-12-31
Completion
2007-11-30

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 NCT00031733 on ClinicalTrials.gov