NCT00580060View on ClinicalTrials.gov

Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Melanoma
Interventions
BIOLOGICAL

GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)

In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 mg), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations.

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00580060 - Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity | Biotech Hunter | Biotech Hunter