Phase I/II Study of Topotecan and Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors

UMIN ID: UMIN000001037

Registered date:16/02/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Relapse/ refractory pediatric solid tumor
• Date of first enrollment: 2008/02/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: Phase I: MTD Phase II: probability of the patients who can tolerate more than 4 courses of chemotherapy at the recommended dosage
• Secondary Outcome: Phase I: incidence of dose limiting toxicity etc. Phase II: progression free survival, overall survival etc.

Key inclusion & exclusion criteria

• Age minimum: 1years-old
• Age maximum: 30years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Group for "making evidence for the drugs which are available in clinical practice in Europe and USA but not available in Japan&quot
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare