Photodynamic Therapy (PDT) for malignant brain tumor in children.

Phase 1

• Conditions: Malignant brain tumor in children

• Registration Number: JPRN-jRCTs031180360
• Lead Sponsor: kawamata takakazu

Brief Summary

We conducted a phase I/II clinical study of PDT for malignant brain tumors in children. No adverse events corresponding to CTCAE grade 3 or higher were observed, indicating that TS can be used safely in children. However, the efficacy of PDT, another objective of this study, could not be demonstrated due to the small number of cases and the diverse clinical backgrounds, including histological diagnosis and treatment received.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2022-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety (including photosensitivity test)(phase I) <br>2. Overall survival (OS) rate at 12 months after PDT (phase II)

Secondary Outcome Measures

Name	Time	Method
1. Overall survival (OS) <br>2. Progression-free survival (PFS) rate at 6 months after PDT. <br>3. Progression-free survival <br>4. Safety (including photosensitivity test)