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Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma

NCT00006243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-01-25

No results posted yet for this study

Summary

This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma

Interventions

BIOLOGICAL

tyrosinase peptide

Given SC

BIOLOGICAL

MART-1:27-35 peptide vaccine

Given SC

BIOLOGICAL

gp100 antigen

Given SC

BIOLOGICAL

incomplete Freund's adjuvant

Given SC

BIOLOGICAL

sargramostim

Given SC

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Svetomir Markovic · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2006-05-31

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 NCT00006243 on ClinicalTrials.gov