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Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

NCT00003222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-12-19

Study results available
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Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

aldesleukin

Systemic subcutaneous delivery of low-dose IL-2.

BIOLOGICAL

gp100 antigen

BIOLOGICAL

incomplete Freund's adjuvant

BIOLOGICAL

sargramostim

BIOLOGICAL

tetanus peptide melanoma vaccine

BIOLOGICAL

tyrosinase peptide

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Craig L. Slingluff, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Primary Completion
2003-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00003222 on ClinicalTrials.gov