A Phase 2 interventional study of irinotecan hydrochloride in Liver Cancer, sponsored by Children's Cancer and Leukaemia Group. Status unknown at 22 sites in 3 countries. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2013-09-17.
Sponsored by Children's Cancer and Leukaemia Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 30 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Children's Cancer and Leukaemia Group is the lead sponsor of 44 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of hepatoblastoma
Refractory or recurrent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Best overall response (complete response and partial response)
Early progression
Death
Disease progression or recurrence
Surgical resection (complete or incomplete)
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Children's Cancer and Leukaemia Group