Treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy
Conditions
Interventions
BNCT for patients with treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy is applied by nuclear reactor
Sponsors
Osaka Medical College
Kyoto University Research Reactor Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed as choroidal malignant melanoma with ophthalmoscopy, fluorescein funduscopy, indoceanin green fluorescence funduscopy, MRI and 123I-IMP-SPECT 2. Patients who have the primary lesion more than 16mm in diameter or have the relapsed inoperable lesion after radio-therapy. 3. Patients with bone marrow, liver, kidney function satisfying the following conditions within 28 days before enrollment Leukocyte count 3,000 /microlitter or more, Platelet count 100,000 /microlitter or more, AST 100 IU/L or less, ALT 100 IU/L or less, Total bilirubin 1.5 mg/dL or less, Serum creatinine 1.2 mg/dL or less
Exclusion criteria
Exclusion criteria: 1. Patients who have systemic metastasis. 2. Pregnant woman or lactating woman 3. Patients with phenylketonuria 4. Patients who have mental illness and judged as difficult for participation of this clinical trial. 5. Patients who have the serum 5-S-CD value more than institutional reference value. 6. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control: Skin lesion of angiosarcoma should be photographed and measured on it, periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expression of adverse events Evaluate adverse events and serious adverse events. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0). | — |
Countries
Japan
Contacts
Public ContactShin-Ichi Miyatake
Osaka Medical College Cancer Center
Outcome results
None listed