The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
1.5 mL administered half intradermally and half subcutaneously.
1 mL administered half intradermally and half subcutaneously
500 mg applied to vaccine site after vaccine administration
MDAnderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Number of Participants With Treatment-related Adverse Events Per Study Arm
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.
Time frame: 6 months
T Cell Response in Peripheral Blood Over Duration of Study Participation
Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
Time frame: 6 months
T Cell Response and Function in Peripheral Blood
CD4+ T cell responses to peptides in the vaccine, and their function
Time frame: 6 months
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2 mL administered half intradermally and half subcutaneously