A Phase I/II trial of Temozolomide and ACNU Combination Chemotherapy for Patients with Recurrent Malignant Glioma
- Conditions
- recurrent malignant glioma
- Registration Number
- JPRN-UMIN000006334
- Lead Sponsor
- Department of Neurosurgery Kyoto University Graduate School of Medicine
- Brief Summary
Eligible patients: 49(I:15, II:40). Median age: 50. Histology: glioblastoma(73%), anaplastic astrocytoma(22%), anaplastic oligodendroglioma(4%). Phase I: MTD: TMZ 150 mg/m2 plus ACNU 40 mg/m2. Phase II: Toxicity: mainly grade 3 or 4 hematological. PFS at 6 and 12 months: 24%(95% CI, 12-35%) and 8% (95% CI, 4-15%). Median PFS: 13 months (95% CI, 9.2-17.2 months). OS at 6 and 12: 78% (95% CI, 67-89%) and 49% (95% CI, 33-57%). Median OS: 11.8 months (95% CI, 8.2-14.5 months).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 49
Not provided
1) After two chemotherapy regimens 2) Co-existence of uncured cancer. 3) Infection with systemic therapy indicated 4) fever over 38 degrees Celsius 5) Co-existence of meningitis 6) Women during pregnancy, possible pregnancy or breast-feeding 7) Psychosis 8) Uncontrollable diabetes mellitus or administration of insulin 9) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 10) Interstitial pneumonia, or fibroid lung 11) Patients who can 't receive gadolinium 12) After stereotactic radiation or boron neutron capture therapy 13) Symptomatic cerebrovascular disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method progression-free survival, response rate, adverse events