Malignant brain tumor in children
Conditions
Interventions
Medication: Talaporfin sodium (Leserphyrin) Dose: Dose-up from 10mg/square-20mg/square-40mg/square in sequence in every 3 cases since initial enrolled case. Finally, single drip intra-venous infusion
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients treated at the department of neurosurgery, Tokyo Women's Medical University, Tokyo, Japan(in both outpatient clinic and admission). 2. Man and woman, over the age of 6 years old and below the age of 20 years old at enrollment. 3. In an initial case, patients who are highly suspicious for primary malignant brain tumor from pre-operative neuro-imaging. In a recurrent case, patient who is diagnosed as primary malignant brain tumor at previous histopathological diagnosis.
Exclusion criteria
Exclusion criteria: 1. Patients without surgical tumor removal. 2. Unusable for Talaporfin Sodium. 3. Non intended histopathological types of brain tumor. 4. Patients necessary for VEP monitoring. 5. Pregnancy or possibility of pregnancy. 6. Patients who are expected poor compliance with light shielding protection. 7. Patients regarded as ineligible by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety (including photosensitivity test)(phase I) 2. Overall survival (OS) rate at 12 months after PDT (phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS) 2. Progression-free survival (PFS) rate at 6 months after PDT. 3. Progression-free survival 4. Safety (including photosensitivity test) | — |
Countries
Japan
Contacts
Public ContactChiba Kentaro
Tokyo Women's Medical University The department of neurosurgery
Outcome results
None listed