Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas
Phase 1
- Conditions
- Recurrent malignant glioma
- Registration Number
- JPRN-UMIN000003983
- Lead Sponsor
- Department of Neurosurgery, Tohoku University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) Cases suffering active cancer 2) Cases suffering meningitis or pneumonia 3) Pregnant or breast feeding woman 4) Karnofsky performance status score less than 30 5) Cases suffering active inflammation 6) Cases with severe liver dysfunction 7) Cases with bone marrow insufficiency 8) Cases with renal failure 9) Cases with hemorrhagic diathesis 10) Cases taking anti-coagulative or anti-platelet agents 11) Cases with psychological diseases 12) Cases with uncontrolled Diabetes Mellitus 13) Cases suffered myocardial infarction within 3 months or cases with unstable angina 14) Cases that have history of pulmonary fibrosis or interstitial pneumoniae
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity Response of targeted lesion
- Secondary Outcome Measures
Name Time Method Best overall response