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GM-CSF as Adjuvant Therapy of Melanoma

NCT00350597 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2006-07-11

No results posted yet for this study

Summary

This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence (Stage II T4, III and IV).

Conditions

  • Malignant Melanoma

Interventions

DRUG

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Melanoma Research Institute

    collaborator UNKNOWN

  • Northern California Melanoma Center

    lead OTHER

Principal Investigators

  • Lynn E. Spitler, MD · Northern California Melanoma Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00350597 on ClinicalTrials.gov