NCT00089219

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF). OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43. * Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. * Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine. PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Conditions

• Intraocular Melanoma
• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	IFA	vaccine adjuvant
BIOLOGICAL	6MHP	melanoma helper peptides
BIOLOGICAL	GM-CSF	vaccine adjuvant

Timeline

• Start date: 2003-07-01
• Primary completion: 2006-05-01
• First posted: 2004-08-05
• Last updated: 2014-11-20

Locations

1 site across 1 country: United States