Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
Recruitment status was Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma|
- Best overall response (complete response and partial response) [ Designated as safety issue: No ]
- Early progression [ Designated as safety issue: No ]
- Death [ Designated as safety issue: No ]
- Disease progression or recurrence [ Designated as safety issue: No ]
- Surgical resection (complete or incomplete) [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Our Lady's Hospital for Sick Children Crumlin|
|Dublin, Ireland, 12|
|Amsterdam, Netherlands, NL-1100 DE|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Institute of Child Health at University of Bristol|
|Bristol, England, United Kingdom, BS2 8AE|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Royal Liverpool Children's Hospital, Alder Hey|
|Liverpool, England, United Kingdom, L12 2AP|
|Great Ormond Street Hospital for Children|
|London, England, United Kingdom, WC1N 3JH|
|Royal London Hospital|
|London, England, United Kingdom, E1 1BB|
|Royal Manchester Children's Hospital|
|Manchester, England, United Kingdom, M27 4HA|
|Sir James Spence Institute of Child Health at Royal Victoria Infirmary|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Belfast Hospital for Sick Children|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Royal Aberdeen Children's Hospital|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Childrens Hospital for Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Study Chair:||Jozsef Zsiros, MD, PhD||Emma Kinderziekenhuis|
|Investigator:||Laurence Brugieres, MD||Institut Gustave Roussy|
|Investigator:||Penelope Brock, MD, PhD||Great Ormond Street Hospital for Children NHS Foundation Trust|