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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 — MEL39  

Melanoma Clinical Trial

Official title:
This is an Open-label, Phase II Study of a Vaccine Comprising Melanoma Peptides and a Tetanus Helper Peptide, Administered in GM-CSF-in-adjuvant. Patients Will be Randomized to Receive One of Two Different Vaccine Regimens. Patients Will be Stratified by Stage of Disease (IIB vs. III vs. IV).

Clinical Trial Summary

This is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB versus III versus IV).

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00938223
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase Phase 2
Start date August 2000
View Details
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