Phase II trial of SPM-011 + BNCT30 for recurrent malignant glioma

Phase II trial of the combination of SPM-011 and BNCT System for recurrent malignant glioma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224670

Enrollment

Registered

2019-05-08

Start date

2016-02-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent malignant glioma

Interventions

investigational material(s) Generic name etc : SPM-011(investigational drug), BNCT30 (investigational device) INN of investigational material : Borofalan(10B) Therapeutic category code : 429 Other ant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Karnofsky performance status of >=60 2. Patients treated with temozolomide and radiation therapy. Patients with relapse or exacerbation of malignant glioma by CT or MRI 3. Patients who underwent radiotherapy with a total dose of 50 Gy - 65 Gy with fractional radiation of about 2 Gy per day for the target lesion site 4. Patients having measurable lesion according to RANO criteria

Exclusion criteria

Exclusion criteria: 1. Patients with active multiple primary cancers 2. Patients with extracranial metastasis 3. Patients with meningeal or intrathecal dissemination or discontinuous two or more tumor lesions 4. Patients treated with Bevacizumab

Design outcomes

Primary

Measure	Time frame
efficacy 1-year survival rate	—

Secondary

Measure	Time frame
safety efficacy Overall survival, progression free survival, progression free survival at 6 months, response rate, duration of response, disease control rate, safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026