Vaccine Therapy in Treating Patients With Melanoma of the Eye

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intraocular Melanoma

Intervention / Treatment
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* Biological: MART-1 antigen
* Biological: NA17-A antigen
* Biological: gp100 antigen
* Biological: tyrosinase peptide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of ocular melanoma No melanoma of the iris Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy No more than 5 weeks since the beginning of primary tumor treatment Measurable disease At least 12.0 mm in largest diameter OR At least 6.0 mm in height HLA-A2 positive No distant metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL Neutrophil count at least 2,000/mm^3 Lymphocyte count at least 700/mm^3 Platelet count at least 100,000/mm^3 No bleeding disorder Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT no greater than 2 times upper limit of normal (ULN) Lactate dehydrogenase no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Gamma glutamyl transpeptidases no greater than 2 times ULN Hepatitis C antibody negative Hepatitis B antigen negative Renal: Creatinine no greater than 2.0 mg/dL Immunologic: No clinical immunodeficiency No autoimmune diseases No inflammatory bowel disease No active infection requiring antibiotics No multiple sclerosis Other: HIV negative No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No other uncontrolled illness No psychological, familial, sociological, or geographical conditions that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent immunotherapy or biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior steroids No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day) Concurrent topical or inhalation steroids allowed No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Prior proton beam therapy allowed Prior brachytherapy without tumor resection allowed Recovered from prior radiotherapy No prior radiotherapy to the spleen No prior pre-enucleation radiotherapy No prior ruthenium Ru 106 as primary therapy alone No concurrent radiotherapy Surgery: See Disease Characteristics Prior transcleral tumor resection allowed Recovered from prior surgery No prior major organ allograft No prior splenectomy Other: No other concurrent investigational drugs No concurrent systemic immunosuppressive drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MART-1 antigen|nan|
|Biological: NA17-A antigen|nan|
|Biological: gp100 antigen|nan|
|Biological: tyrosinase peptide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ciliary body and choroid melanoma, medium/large size