Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma

Stage IV Melanoma Clinical Trial

Official title: A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IIC/III AND IV MELANOMA

Status Completed

Clinical Trial Summary

This pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells

Clinical Trial Description

PRIMARY OBJECTIVES I. To perform a two-cohort, two-stage phase II two cohort pilot trial of a multi-peptide melanoma vaccine (multi-epitope melanoma peptide vaccine) with Montanide ISA 51 (incomplete Freund's adjuvant) or ISA 51 VG (Montanide ISA 51 VG) with adjuvant 7909 (agatolimod sodium) to define the safety and tolerability of each of the regimens, and to evaluate immune reactivity to a tyrosinase/gp100/MAGE-3 class I peptide vaccine combined with Montanide ISA 51 or ISA 51 VG with CpG adjuvant 7909 in human leukocyte antigen (HLA) class I A1, A3 or A11 and B44 matched patients with surgically resected stages IIC, III and IV melanoma.

OUTLINE: Patients are assigned to 1 of 2 treatment cohorts.

COHORT I: Patients receive multi-epitope peptide melanoma peptide vaccine with incomplete Freund's adjuvant and agatolimod sodium subcutaneously (SC) at 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity.

COHORT II: Patients receive multi-epitope peptide melanoma peptide vaccine with Montanide ISA 51 VG and agatolimod sodium SC at 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years, and then annually thereafter. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Ciliary Body and Choroid Melanoma, Small Size
• Extraocular Extension Melanoma
• Iris Melanoma
• Melanoma
• Metastatic Intraocular Melanoma
• Mucosal Melanoma
• Recurrent Intraocular Melanoma
• Recurrent Melanoma
• Stage IIC Melanoma
• Stage IIIA Intraocular Melanoma
• Stage IIIA Melanoma
• Stage IIIB Intraocular Melanoma
• Stage IIIB Melanoma
• Stage IIIC Intraocular Melanoma
• Stage IIIC Melanoma
• Stage IV Intraocular Melanoma
• Stage IV Melanoma
• Uveal Neoplasms

• NCT number: NCT00085189
• Study type: Interventional
• Source: University of Southern California
• Status: Completed
• Phase: Phase 2
• Start date: May 2004
• Completion date: September 2007