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Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

NCT00436930 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-01-10

No results posted yet for this study

Summary

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for melanoma.

PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to compare how well they work when given together with GM-CSF in treating patients with recurrent or metastatic melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

autologous tumor cell vaccine

Given subcutaneously

BIOLOGICAL

sargramostim

Given subcutaneously

BIOLOGICAL

therapeutic autologous dendritic cells

Given subcutaneously

Sponsors & Collaborators

  • Hoag Memorial Hospital Presbyterian

    lead OTHER

Principal Investigators

  • Robert O. Dillman, MD, FACP · Hoag Memorial Hospital Presbyterian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-10-31
Completion
2012-10-31

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 NCT00436930 on ClinicalTrials.gov