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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Vincent Brichard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cliniques universitaires Saint-Luc

Authority:

United States: Federal Government

Study ID:

EORTC-18001 -88001

NCT ID:

NCT00036816

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • ciliary body and choroid melanoma, medium/large size
  • Melanoma
  • Uveal Neoplasms

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