Status:
UNKNOWN
Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Liver Cancer
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00287976
Start Date
April 1 2003
Last Update
September 17 2013
Active Locations (22)
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1
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
2
Emma Kinderziekenhuis
Amsterdam, Netherlands, NL-1100 DE
3
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
4
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE