Phase I study of Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide against recurrent gliomas at brainstem
- Conditions
- recurrent glioma at brainstem
- Registration Number
- JPRN-UMIN000005125
- 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
- 15
Not provided
1) Co-existence of uncured cancer. 2) Co-existence of meningitis or pneumonia that require treatment. 3) Pregnant women or possibly pregnant women or breast feeding women 4) Existence of active inflammation (CRP>2.0) 5) Severe liver dysfunction (GOT>100 IU/l or GPT>100 IU/l) 6) Existence of bone marrow insufficiency: WBC(<3,000/mm3), Hb (<8.0 g/dl), Plt(<10x104/mm3) 7) Renal dysfunction: Cre (>1.5 mg/dl) 8) Existence of hemorrhagic diathesis 9) Patients taking anti-coagulants or anti-platelet agents. 10) Existence of mental disorder that makes participation to this study difficult. 11) Poor control of diabetes mellitus 12) Past history of acute myocardial infarction within 3 months or unstable angina. 13) Past history of pulmonary fibrosis or interstitial pneumoniae.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of maximum tolerable concentration of AC
- Secondary Outcome Measures
Name Time Method Response rate, 6 months survival, Overall survival