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Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

NCT00037037 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-12-18

No results posted yet for this study

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

MAGE-10.A2

BIOLOGICAL

MART-1 antigen

BIOLOGICAL

NY-ESO-1 peptide vaccine

BIOLOGICAL

sargramostim

BIOLOGICAL

tyrosinase peptide

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Herbert Irving Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Kyriakos P. Papadopoulos, MD · Herbert Irving Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31

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 NCT00037037 on ClinicalTrials.gov