Chemotherapy for recurrent malignant glioma with combined usage of temozolomide and GSK3beta-inhibiting drugs
Phase 1
- Conditions
- Recurrent glioblastoma
- Registration Number
- JPRN-UMIN000005111
- Lead Sponsor
- Department of Neurosurgery Kanazawa University
- Brief Summary
Seven patients were enrolled in this study. Median OS after first recurrence was 11.2 (95% CI, 3.8-18.6) months in patients treated with concomitant CLOVA cocktail with maintenance TMZ although they were classified into RPA class 7 wherein the median survival duration was estimated as 4.9 months, compared to median OS of 4.3 (95% CI, 2.5-6.1) months in historical control group (log-rank test, P = 0.004). The concomitant CLOVA cocktail with TMZ was safe and well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy to the drugs administered. 2) Patients who are pregnant and/or breast feeding. 3) Any patients disqualified by a study physician because of medical, psychological, or any other factors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Efficacy: response on MRI and progression-free survival