recurrent malignant glioma
Conditions
Interventions
Temozolomide(150mg/m2 for 5days) (day 1,2,3,4,5) + ACNU(30-40mg/m2)(day14)
Sponsors
Department of Neurosurgery Kyoto University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Age 20 years old or over 3) Expected survival time: more than 3 months. 4) Recurrence or regrowth of supratentorial tumor MRI 5) Anaplastic astrocytoma or glioblastoma 6) After initial treatment with radiation plus temozolomide 7) Gadolinium-enhanced tumor to measure 8) Tumor sample for central pathology review 9) Karnofsky Performance Status is 60% or more. 10) No prior chemotherapy or radiation therapy for any malignant diseases 11) Sufficient organ functions 12) Appropriate systemic condition: Neutrophil >1,500/mm3, Hb >8.0 g/dl, Plt>10x104/mm3, AST(GOT) <100 IU/l, ALT(GPT) <100 IU/l, total bilirubin <1.5 mg/dL, Cr <1.5 mg/dl.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, response rate, adverse events | — |
Countries
Japan
Contacts
Public ContactYoshiki Arakawa
Kyoto University Graduate School of Medicine Department of Neurosurgery
Outcome results
None listed