Vaccine Therapy in Treating Patients With Melanoma of the Eye

Intraocular Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00036816
• Other study ID #: EORTC-18001 -88001
• Secondary ID: EORTC-18001EORTC
• Status: Terminated
• Phase: Phase 3
• First received: May 13, 2002
• Last updated: September 20, 2012
• Start date: February 2002

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Uveal Neoplasms

Intervention

Biological:
• MART-1 antigen

• NA17-A antigen

• gp100 antigen

• tyrosinase peptide

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Denmark,