NIPH Clinical Trials Search

UMIN ID: UMIN000001037

Registered date:16/02/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRelapse/ refractory pediatric solid tumor
Date of first enrollment2008/02/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
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


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

Key inclusion & exclusion criteria

Age minimum1years-old
Age maximum30years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name Hiroshi Kawamoto
Address 15-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan
Telephone 03-3542-2511
Affiliation study coordinator National Cancer Center Hospital
scientific contact
Name Atsushi Ogawa
Address 2-15-3 Kawagishi-cho, Chuo-ku, Niigata 951-8566, Japan Japan
Telephone 025-266-5111
Affiliation Niigata Cancer Center Hospital Pediatric Division