Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
N/A
20 Years
Both
Liver Cancer
Trial Information
Irinotecan Single-Drug Treatment For Children 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best overall response (complete response and partial response)
Safety Issue:
No
Principal Investigator
Jozsef Zsiros, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Emma Kinderziekenhuis
Authority:
United States: Federal Government
Study ID:
CDR0000454758
NCT ID:
NCT00287976
Start Date:
April 2003
Completion Date:
Related Keywords:
- Liver Cancer
- childhood hepatoblastoma
- recurrent childhood liver cancer
- Liver Neoplasms
- Hepatoblastoma
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