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Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma

NCT00616564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-05-03

No results posted yet for this study

Summary

High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.

Conditions

  • Malignant Melanoma

Interventions

DRUG

GM-CSF

Concomitant Priming with GM-CSF

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Chiron Corporation

    collaborator INDUSTRY

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Jose Lutzky, M.D. · Mount Sinai Medical Center Miami Beach

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00616564 on ClinicalTrials.gov