Phase I/II Study of Topotecan and Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors - TI chemotherapy for Relapsed Pediatric Solid Tumor pI/II

Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan"0 sites40 target enrollmentFebruary 16, 2008

ConditionsRelapse/ refractory pediatric solid tumor

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapse/ refractory pediatric solid tumor
Sponsor: Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan"
Enrollment: 40
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Recommended dose of topotecan with ifosfamide 1.2g/m2/d was determined to be level0. Currently phaseII is ongoing.

Registry

who.int

Start Date

February 16, 2008

End Date

December 31, 2013

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan"

Eligibility Criteria

Inclusion Criteria

Not provided

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