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Phase III Randomized Study of Adjuvant NA17-A and Melanoma Differentiation Peptides in HLA-A2-Positive Patients With Primary Ocular Melanoma at High Risk of Relapse
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy in Treating Patients With Melanoma of the
Eye
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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Over 18
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Other
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EORTC-18001 EORTC-88001, NCT00036816
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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.
Entry Criteria Disease Characteristics:
- Diagnosis of ocular melanoma
- 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
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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Hemoglobin at least 9 g/dL
- Neutrophil count at least 2,000/mm3
- Lymphocyte count at least 700/mm3
- Platelet count at least 100,000/mm3
- 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
Expected Enrollment A total of 600 patients (300 per treatment arm) will be accrued for this study
within 2 years. 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.
Trial Contact Information
Trial Lead Organizations European Organization for Research and Treatment of Cancer | | | Vincent Brichard, MD, Protocol chair(Contact information may not be current) | | | |
European Organization for Research and Treatment of Cancer | | | Jan Prause, MD, Protocol chair | | | |
Registry Information | | 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 | | Trial Start Date | | 2002-02-04 | | Registered in ClinicalTrials.gov | | NCT00036816 | | Date Submitted to PDQ | | 2002-03-07 | | Information Last Verified | | 2006-06-08 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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