Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
NCT ID: NCT00287976
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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irinotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Jozsef Zsiros, MD, PhD
Role: STUDY_CHAIR
Emma Kinderziekenhuis
Laurence Brugieres, MD
Role:
Gustave Roussy, Cancer Campus, Grand Paris
Penelope Brock, MD, PhD
Role:
Great Ormond Street Hospital for Children NHS Foundation Trust
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Emma Kinderziekenhuis
Amsterdam, , Netherlands
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Royal London Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CCLG-LT-2003-01
Identifier Type: -
Identifier Source: secondary_id
CCLG-IRINOTECAN
Identifier Type: -
Identifier Source: secondary_id
EU-20589
Identifier Type: -
Identifier Source: secondary_id
CDR0000454758
Identifier Type: -
Identifier Source: org_study_id