Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma
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.
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Biological: recombinant interleukin-12
Biological: tyrosinase peptide
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma|
|Study Start Date:||November 1998|
|Study Completion Date:||September 2004|
|Primary Completion Date:||November 1999 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003339
|United States, California|
|Beckman Research Institute, City of Hope|
|Duarte, California, United States, 91010|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Study Chair:||Jeffrey S. Weber, MD, PhD||University of Southern California|