Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.
|Intraocular Melanoma Melanoma (Skin)||Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: ipilimumab Biological: tyrosinase peptide Procedure: adjuvant therapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma|
|Study Start Date:||October 2001|
|Study Completion Date:||June 2005|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
- Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma.
- Determine if this regimen causes antigen-specific T-cell activation in these patients.
- Determine the clearance profile of this regimen in these patients.
- Assess the development of host immune response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4).
Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4, 5, 8, and 11 months in the absence of disease progression or unacceptable toxicity.
Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025181
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089|
|Study Chair:||Jeffrey S. Weber, MD, PhD||University of Southern California|