A phase I study of SPM-011 and BNCT30 in patients with recurrent malignant glioma

An open label dose escalation study to investigate the safety and tolerability of boron neutron capture therapy (BNCT) with SPM-011 and BNCT treatment system (BNCT30) in patients with recurrent malignant glioma (WHO grade III and grade IV)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051210053

Enrollment

Registered

2021-07-16

Start date

2012-11-14

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

SPM-011: After 2 hours of administration at 200 mg/kg/hr, the dose was slowed down to 100 mg/kg/hr, for a total dose of 500 mg/kg. Neutron irradiation by BNCT30: Neutron irradiation was performed duri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Karnofsky performance status >= 60 2. Patients with recurrent malignant glioma confirmed by imaging or histological diagnosis with previous radiotherapy to the target lesion. 3. Patients who have received 50 Gy to 65 Gy of prior radiation therapy to the target lesion and more than 180 days have passed since the last irradiation.

Exclusion criteria

Exclusion criteria: 1. Patients with active multiple primary cancers 2. Patients with meningeal dissemination or two or more discontinuous tumor lesions 3. Patients who are using steroids other than for the treatment of cerebral edema or who have complications requiring systemic administration of steroids

Design outcomes

Primary

Measure	Time frame
Safety, tolerability	—

Secondary

Measure	Time frame
Pharmacokinetics of SPM-011, survival	—

Contacts

Public ContactSeinori Iwasaki

STELLA PHARMA CORPORATION

iwasaki@stella-pharma.co.jp+81-6-4707-1516

Outcome results

None listed

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