Vaccine Therapy in Treating Patients With Melanoma of the Eye
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.
Biological: MART-1 antigen
Biological: NA17-A antigen
Biological: gp100 antigen
Biological: tyrosinase peptide
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Study Of Adjuvant Immunization With The NA17.A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse|
|Study Start Date:||February 2002|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
- Determine whether adjuvant NA17-A and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse.
- Determine whether this regimen increases survival of these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vaccination with NA17-A and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years.
- Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years.
All patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036816
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|University of Copenhagen|
|Copenhagen, Denmark, 2100|
|Study Chair:||Vincent Brichard, MD||Cliniques universitaires Saint-Luc|
|Study Chair:||Jan U. Prause, MD||University of Copenhagen|