Phase II trial of SPM-011 + BNCT30 for recurrent malignant glioma
Phase 2
Completed
- Conditions
- Recurrent malignant glioma
- Registration Number
- JPRN-jRCT2080224670
- Lead Sponsor
- STELLA PHARMA CORPORATIO
- Brief Summary
The 1-year survival rate was 79.2% (95% CI: 57.0-90.8) and the median OS (mOS) was 18.9 months (12.9-not estimable) with BNCT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 27
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>1-year survival rate
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Overall survival, progression free survival, progression free survival at 6 months, response rate, duration of response, disease control rate, safety