Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Melanoma of the Eye

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Over 18 Other EORTC-18001 EORTC-88001, NCT00036816

Objectives

1. 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.
2. Determine whether this regimen increases survival of these patients.
3. Determine the toxicity of this regimen in these patients.

Entry Criteria

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

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

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/mm³
• Lymphocyte count at least 700/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Vincent Brichard, MD, Protocol chair(Contact information may not be current)		Ph: 32-2-764-1111

European Organization for Research and Treatment of Cancer

Jan Prause, MD, Protocol chair		Ph: 45-3532-6070 Email: jup@eyepath.ku.dk

Registry Information
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
Trial Start Date		2002-02-04
Registered in ClinicalTrials.gov		NCT00036816
Date Submitted to PDQ		2002-03-07
Information Last Verified		2006-06-08