Relapse/ refractory pediatric solid tumor
Conditions
Interventions
TI chemotherpay in which ifosfamide IV over 1 hours followed by topotecan IV over 2 hours on days 1-5, to be repeated every 3 weeks
Sponsors
Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. neuroblastoma, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family of tumor, retinoblastoma, Wilm's tumor, hepatoblastoma, osteosarcoma, other bone or tissue malignant tumor, meduloblastoma 2. relapse or progression following disease specific first-line standard chemotherapies 3. <= 20 courses prior chemotherapy 4. no or 5 years > prior allogenic stem cell transplantation 5. no prior topotecan containing chemotherapy 6. > 21 days since prior antitumor cytotoxic agents 7. > 21 days since prior radiation therapy 8. > 14 days since prior surgery (containing open biopsy) 9. evidence of progression in clinical signs or symptoms or on imaging studies 10. 0-2 in ECOG PS 11. no signs or symptoms equivalent to CTC-AE Grade3 neurology adverse events 12. confirming the following laboratory results within 14 days (1) Absolute neutrophil count >= 1,000/mm~3 (at least 4days since prior G-CSF administration) (2) Platelet count >= 75,000/mm~3 (platelet transfusions allowed) (3) serum total Bilirubin <= 1.2mg/dl (4) ALT <= 100 IU/l (5) serum Potassium >= 3.0mmol/l (6) Creatinine adjusted according to age as follows: <= 0.6 mg/dl (1 year-23 months) <= 0.8 mg/dl (2 years-5 years) <= 0.9 mg/dl (6 years-9 years) <= 1.1 mg/dl (10 years-12 years [male]) <= 1.0 mg/dl (10 years-12 years [female]) <= 1.5 mg/dl (13 years-15 years [male]) <= 1.2 mg/dl (13 years and over [female]) <= 1.7 mg/dl (16 years and over [male]) 13. no episode of Status Epilepticus or at least 22 days since last episode of Status Epilepticus 14. no episode of Status Epilepticus within 48 hours after administration of ifosfamide 15. legal adult: Written informed consent 16. 16 years and over, but, no legal adult: written informed consent from both patient and legal guardian 17. 15 years and under: written informed consent from legal guardian
Exclusion criteria
Exclusion criteria: 1. Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment 2. Active infection requiring systemic medication 3. abnormality in electrocardiogram tested within 28 days, requiring intervention 4. respiratory or heart disorder requiring oxygen supply, except from malignant pleural effusion 5. abnormality in electroencephalogram and requiring medication for neuropsychological signs or symptoms 6. Women during pregnancy or breast-feeding 7. Psychosis 8. Systemic steroids medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: MTD Phase II: probability of the patients who can tolerate more than 4 courses of chemotherapy at the recommended dosage | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: incidence of dose limiting toxicity etc. Phase II: progression free survival, overall survival etc. | — |
Countries
Japan
Contacts
Public ContactHiroshi Kawamoto
study coordinator National Cancer Center Hospital
Outcome results
None listed