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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Vincent Brichard, MD
Cliniques universitaires Saint-Luc
United States: Federal Government