Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: University of Virginia
No Placebo Group
Trial Summary
What is the purpose of this trial?
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
Eligibility Criteria
Inclusion Criteria
Diagnosis of stage IIIB, IIIC, or IV melanoma
HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
Brain metastases allowed at the discretion of the principle investigator Age
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Treatment Details
Interventions
- 6MHP (Cancer Vaccine)
- GM-CSF (Cytokine)
- IFA (Immunotherapy)
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Arm C. 6MHP vaccine 800 mcgExperimental Treatment3 Interventions
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Group II: Arm B. 6MHP vaccine 400 mcgExperimental Treatment3 Interventions
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Group III: Arm A. 6MHP vaccine 200 mcgExperimental Treatment3 Interventions
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Virginia Cancer CenterCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
National Cancer Institute (NCI)Collaborator