recurrent malignant glioma in children
Conditions
Interventions
Both Bevacizumab and irinotecan is administered intravenously over 90 minutes, once every 2 weeks: day 1, 15 of a 4-week cycle. Bevacizumab dose is 10mg/kg and ironotecan dose is 340/m2 in patients on
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) Patients histopathologically or radiologically diagnosed as recurrent malignant glioma in children. 2) Performance Status is 2 or less, and 3 in cases with neurological deficits. 3) Karnofsky Performance Status is at least 40%. 4) Patient's data from blood sample must satisfy the followings: Neutrophil: more than 1500/mm3 Hb: more than 7.0g/dl Platelet: more than 100,000/mm3 5) At least one month since prior anticancer therapy 6) No residual hemorrhagic lesions 7) Written informed consent must be obtained from patients or legally acceptable representatives.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1)Patients taking anticoagulant agents 2)Patients with the past history of thrombosis 3)Patients with the past history of intestinal hemorrhage or lung hemorrhage 4)Past history of stereotactic radiosurgery for intracranial lesions may be included in exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, objective tumor response, response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, incidence of adverse event | — |
Countries
Japan
Contacts
Public ContactNaoki Kagawa
Osaka University Graduate School of Medicine Department of Neurosurgery
Outcome results
None listed