NCT00036816

Vaccine Therapy in Treating Patients With Melanoma of the Eye

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Intraocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	MART-1 antigen
BIOLOGICAL	NA17-A antigen
BIOLOGICAL	gp100 antigen
BIOLOGICAL	tyrosinase peptide

Timeline

• Start date: 2002-02-01
• Primary completion: 2003-02-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

2 sites across 2 countries: Belgium, Denmark