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
| Registry | NCT00036816 |
|---|---|
| Status | Terminated - low accrual |
| Phase | Phase 3 |
| Study type | Interventional; randomized, treatment |
| Enrollment | 13 (Actual) |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC (Network) |
| Conditions | Intraocular Melanoma |
| Interventions | MART-1 antigen, NA17-A antigen, gp100 antigen, tyrosinase peptide (Biological) |
| Dates | start 2002-02-01, primary completion 2003-02-01, first posted 2003-01-27, last updated 2012-09-24 |
| Locations | 2 sites in Belgium, Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Intraocular Melanoma All trials of MART-1 antigen All trials of NA17-A antigen
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.
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.
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| University of Copenhagen | Copenhagen | Denmark |