Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of hepatoblastoma Refractory or recurrent disease Failed prior first-line or second-line treatment Metastatic disease allowed Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Elevated serum alpha-fetoprotein (AFP) allowed No hepatocellular carcinoma PATIENT CHARACTERISTICS: Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients > 10 years of age Life expectancy > 8 weeks Hemoglobin > 8 g/dL Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Serum bilirubin ≤ 2 times normal AST/ALT ≤ 2 times normal Serum creatinine ≤ 3 times normal Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate) Not pregnant or nursing No severe uncontrolled infection or enterocolitis PRIOR CONCURRENT THERAPY: Recovered from toxicity of prior therapy No chemotherapy within 3 weeks prior to study entry No prior irinotecan No other concurrent anticancer therapy

Ages Eligible for Study
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Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response (complete response and partial response) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early progression |  |  | 
| Death |  |  | 
| Disease progression or recurrence |  |  | 
| Surgical resection (complete or incomplete) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood hepatoblastoma, recurrent childhood liver cancer