Irinotecan singele drug treatment for children with refractory or relapsed hepatoblastoma

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002925-29-AT

Enrollment

Registered

2005-08-16

Start date

2005-09-20

Completion date

Unknown

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory or recurrent hepatoblastoma

Interventions

Trade Name: Campto Product Name: campto Product Code: Irinotecan Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the biologic activity of Irinotecan single drug treatment - when given on a prolonged schedule - in children with refractory or recurrent hepatoblastoma measured by tumour response rate and rate of early progression.;Secondary Objective: To assess the duration of response within the time frame of the study in children showing stable disease or an objective response to Irinotecan treatment. To estimate overall survival of children with refractory of recurrent hepatoblastoma treated with Irinotecan on a prolonged schedule. To assess time to progression of children with refractory or recurrent hepatoblastoma treated with Irinotecan on a prolonged schedule. To assess a rate of resectability in children with refractory or recurrent non resectable hepatoblastoma when treated with Irinotecan on a prolonged schedule. To assess toxicity of Irinotean in children when given on a prolonged schedule.;Primary end point(s): Response rate: best overall response Overall survival: death Time to progression: disease progression Duration of overall response: disease progression or recurrence Resection rate: surgical resection	—

Measure

Time frame

Main Objective: To assess the biologic activity of Irinotecan single drug treatment - when given on a prolonged schedule - in children with refractory or recurrent hepatoblastoma measured by tumour response rate and rate of early progression.;Secondary Objective: To assess the duration of response within the time frame of the study in children showing stable disease or an objective response to Irinotecan treatment. To estimate overall survival of children with refractory of recurrent hepatoblastoma treated with Irinotecan on a prolonged schedule. To assess time to progression of children with refractory or recurrent hepatoblastoma treated with Irinotecan on a prolonged schedule. To assess a rate of resectability in children with refractory or recurrent non resectable hepatoblastoma when treated with Irinotecan on a prolonged schedule. To assess toxicity of Irinotean in children when given on a prolonged schedule.;Primary end point(s): Response rate: best overall response Overall survival: death Time to progression: disease progression Duration of overall response: disease progression or recurrence Resection rate: surgical resection

—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026