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Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma

NCT00006385 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2011-11-08

No results posted yet for this study

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

MART-1 antigen

BIOLOGICAL

gp100 antigen

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

recombinant interferon alfa

BIOLOGICAL

sargramostim

BIOLOGICAL

tyrosinase peptide

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • John M. Kirkwood, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2006-10-31

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 NCT00006385 on ClinicalTrials.gov