Vaccine Therapy in Treating Patients With Melanoma of the Eye

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
  • Denmark
      • Copenhagen, Denmark, 2100
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Vincent Brichard, MD, Cliniques universitaires Saint-Luc
  • Study Chair: Jan U. Prause, MD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

May 13, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-18001 -88001
  • EORTC-18001
  • EORTC-88001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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