Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Melanoma of the Eye
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
NCT00036816CI-TRIAL-00008063terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100 antigen | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
| NA17-A antigen | Biological | — | UNRESOLVED |
| tyrosinase peptide | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.