Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
- Conditions
- Liver Cancer
- Registration Number
- NCT00287976
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma.
Secondary
* Determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug.
* Determine the time to progression and overall survival of patients treated with this drug.
* Determine the rate of resectability in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo evaluation for tumor resectability after courses 2, 3, or 4. Patients whose disease is considered resectable at any of these time points proceed to surgery.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best overall response (complete response and partial response)
- Secondary Outcome Measures
Name Time Method Early progression Death Disease progression or recurrence Surgical resection (complete or incomplete)
Trial Locations
- Locations (21)
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom
Royal London Hospital
🇬🇧London, England, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Emma Kinderziekenhuis
🇳🇱Amsterdam, Netherlands
Institute of Child Health at University of Bristol
🇬🇧Bristol, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom