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

Melanoma (Skin) Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

• NCT number: NCT00089219
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2003