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

JRCT ID: jRCT2051210053

Registered date:16/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Recurrent malignant glioma
• Date of first enrollment: 14/11/2012
• Target sample size: 9
• Study type: Interventional

Intervention(s)

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).

Outcome(s)

• Primary Outcome: Safety, tolerability
• Secondary Outcome: Pharmacokinetics of SPM-011, survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Miyatake Shin-ichi