Vaccine Therapy in Treating Patients With Melanoma of the Eye

NCT ID: NCT00036816

Last Updated: 2012-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28

Brief 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

Keywords

ciliary body and choroid melanoma, medium/large size

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

MART-1 antigen

Intervention Type: BIOLOGICAL

NA17-A antigen

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Brichard, MD

Role: STUDY_CHAIR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Jan U. Prause, MD

Role: STUDY_CHAIR

University of Copenhagen

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

University of Copenhagen

Copenhagen, , Denmark

Countries

Belgium; Denmark

Other Identifiers

EORTC-18001

Identifier Type: -

Identifier Source: secondary_id

EORTC-88001

Identifier Type: -

Identifier Source: secondary_id

EORTC-18001 -88001

Identifier Type: -

Identifier Source: org_study_id