Vaccine Therapy in Treating Patients With Melanoma of the Eye

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00036816
First received: May 13, 2002
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Intraocular Melanoma
Biological: MART-1 antigen
Biological: NA17-A antigen
Biological: gp100 antigen
Biological: tyrosinase peptide
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 13
Study Start Date: February 2002
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036816

Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Denmark
University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00036816     History of Changes
Other Study ID Numbers: EORTC-18001 -88001, EORTC-18001, EORTC-88001
Study First Received: May 13, 2002
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
ciliary body and choroid melanoma, medium/large size

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 29, 2014