臨床研究等提出・公開システム

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)

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

Miyatake Shin-ichi

Osaka Medical and Pharmaceutical University Hospital

2-7 Daigaku-machi, Takatsuki City, Osaka, Osaka

shinichi.miyatake@ompu.ac.jp

Iwasaki Seinori

STELLA PHARMA CORPORATION

ORIX Kouraibashi Bldg.8F 3-2-7 Kouraibashi Chuo-ku, Osaka 541-0043 Japan

+81-6-4707-1516

iwasaki@stella-pharma.co.jp

Complete

Nov. 14, 2012

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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

Both

Recurrent malignant glioma

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 during the administration of 100 mg/kg/hr of SPM-011. Three neutron dose levels were set as skin doses (low dose group: 5.5 Gy-Eq, intermediate dose group: 7 Gy-Eq, high dose group: 8.5 Gy-Eq).

Safety, tolerability

Pharmacokinetics of SPM-011, survival

+81-72-683-1221

Sept. 24, 2012

No

none