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Vaccine Therapy in Treating Patients With Melanoma of the Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036816
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Biological: MART-1 antigen Biological: NA17-A antigen Biological: gp100 antigen Biological: tyrosinase peptide Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : February 2002
Actual Primary Completion Date : February 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • 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


  • 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


  • Creatinine no greater than 2.0 mg/dL


  • No clinical immunodeficiency
  • No autoimmune diseases
  • No inflammatory bowel disease
  • No active infection requiring antibiotics
  • No multiple sclerosis


  • 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


Biologic therapy:

  • No other concurrent immunotherapy or biologic therapy


  • 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


  • 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


  • See Disease Characteristics
  • Prior transcleral tumor resection allowed
  • Recovered from prior surgery
  • No prior major organ allograft
  • No prior splenectomy


  • No other concurrent investigational drugs
  • No concurrent systemic immunosuppressive drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036816

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Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Vincent Brichard, MD Cliniques universitaires Saint-Luc
Study Chair: Jan U. Prause, MD University of Copenhagen
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00036816    
Other Study ID Numbers: EORTC-18001 -88001
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
ciliary body and choroid melanoma, medium/large size
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas