Liver Cancer Clinical Trial
Official title:
Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
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
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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