Evaluation of the Immunogenicity of Vaccination With Multiple Synthetic Melanoma Peptides With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With Advanced Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 31, 2000

Primary Completion Date

November 30, 2003

Conditions
Melanoma
Interventions
BIOLOGICAL

4-peptide and 12-peptide melanoma vaccines

"Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B.~Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.~Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.~All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN)."

Trial Locations (1)

22908

University of Virginia, Charlottesville

All Listed Sponsors
lead

Craig L Slingluff, Jr

OTHER

NCT00938223 - Evaluation of the Immunogenicity of Vaccination With Multiple Synthetic Melanoma Peptides With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With Advanced Melanoma | Biotech Hunter | Biotech Hunter