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Vaccine Therapy in Treating Patients With Melanoma of the Eye

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vaccine Therapy in Treating Patients With Melanoma of the Eye
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
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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Active Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Intraocular Melanoma
Intervention  Drug: MART-1 antigen
Drug: NA17-A antigen
Drug: gp100 antigen
Drug: tyrosinase peptide
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  February 2002
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Belgium,   Denmark
Administrative Information Fields
NCT ID  NCT00036816
Organization ID CDR0000069325
Secondary IDs †† EORTC-18001, EORTC-88001
Study Sponsor  European Organization for Research and Treatment of Cancer
Collaborators ††
Investigators 
Study Chair:     Vincent Brichard, MD     Cliniques Universitaires Saint-Luc    
Study Chair:     Jan U. Prause, MD     University of Copenhagen    
Information Provided By National Cancer Institute (NCI)
Verification Date June 2006
First Received Date  May 13, 2002
Last Updated Date May 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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