Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma

Phase 2

Completed

• Conditions: Intraocular Melanoma; Melanoma (Skin)

• Registration Number: NCT00003339
• Lead Sponsor: University of Southern California

Brief Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells.

PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma.

Detailed Description

OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in HLA-A2 positive patients with stage III or IV melanoma.

OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy (immunotherapy or chemotherapy vs surgery only). Patients are randomized to receive 1 of 2 treatment arms: Arm I: Following surgery, patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Arm II: Following surgery, patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Patients are followed at 2-4 weeks, then every 3 months for 2 years after resection, then every 6 months for 3 years, and then yearly if without evidence of disease.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.

Study Timeline

• Study Start: 1998-11
• Primary Completion: 1999-11
• Study First Submitted: 1999-11-01
• Study Completion: 2004-09
• Study First Submitted QC: 2004-09-10
• Study First Posted: 2004-09-13
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States