Recurrent or refractory solid tumors
Conditions
Interventions
Bevacizumab and irinotecan are administered i.v., once every 2 weeks: days 1, 15 and 29 of a 6-week cycle. Irinotecan is administered over 90 min before the bevacizumab infusion. Bevacizumab is admini
Sponsors
Osaka City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of pediatric solid tumors or brain tumors. Recurrent, progressive, or refractory disease (must have received prior therapy) No evidence of CNS hemorrhage within the past 2 weeks. At least 3 weeks since prior anticancer chemotherapy. More than 7 days since prior minor surgery, and at least 6 weeks since prior major surgery. At least 3 months since prior autologous bone marrow or stem cell transplantation. More than 12 weeks since prior irradiation. No concurrent therapeutic anticoagulation. No concurrent non-steroidal anti-inflammatory drugs. Karnofsky performance status (PS) 50-100%. At least 72 hours since prior G-CSF. Absolute neutrophil count >500/mm3 Platelet count >75000/mm3 ALT and AST < 2.5 times ULN Bilirubin < 1.5 mg/dl No uncontrolled systemic hypertension. No stroke, myocardial infarction, unstable angina, or peripheral vascular disease. No evidence of bleeding diathesis, or coagulopathy. No significant traumatic injury within the past 6 weeks. No abdominal fistula or gastrointestinal perforation within the past 6 months. No pregnant or nursing.
Exclusion criteria
Exclusion criteria: Has a double cancer. Has a cardiac disease for which treatment is necessary. Has a psychosis or mental disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the DLTs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimate the rate of treatment-related toxicity. | — |
Countries
Japan
Contacts
Public ContactKeiko Okada
Osaka City General Hospital Pediatric Hematology/Oncology
Outcome results
None listed