Irinotecan singele drug treatment for children with refractory or relapsed hepatoblastoma

• Conditions: Refractory or recurrent hepatoblastoma

• Registration Number: EUCTR2005-002925-29-AT
• Lead Sponsor: niversity Childrens Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-16
• Last Update Posted: 27 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Refractory or recurrent hepatoblastoma
Measarable disease
Age under 21 years
Good perfomance status
Adequate rhino and liver function
Normal metabolic parameters
No history of severe enterocolitis
Life expectancy greater than 8 weeks

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

hepatocelullar carcinoma
Chemotherapy within 3 weeks before start of the study
Prior treatment with Irinotecan
Any concurrent anticancer therapy
Severe uncontrolled infection or enterocolitis
Pregnancy or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified