- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287976
Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
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.
Study Overview
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Dublin, Ireland, 12
- Our Lady's Hospital for Sick Children Crumlin
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Amsterdam, Netherlands, NL-1100 DE
- Emma Kinderziekenhuis
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England
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Birmingham, England, United Kingdom, B4 6NH
- Birmingham Children's Hospital
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Bristol, England, United Kingdom, BS2 8AE
- Institute of Child Health at University of Bristol
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Cambridge, England, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital
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Leeds, England, United Kingdom, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, United Kingdom, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, United Kingdom, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, United Kingdom, E1 1BB
- Royal London Hospital
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London, England, United Kingdom, WC1N 3JH
- Great Ormond Street Hospital for Children
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Manchester, England, United Kingdom, M27 4HA
- Royal Manchester Children's Hospital
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Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
- Sir James Spence Institute of Child Health at Royal Victoria Infirmary
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Nottingham, England, United Kingdom, NG7 2UH
- Queen's Medical Centre
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Oxford, England, United Kingdom, 0X3 9DU
- Oxford Radcliffe Hospital
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Sheffield, England, United Kingdom, S10 2TH
- Children's Hospital - Sheffield
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
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Sutton, England, United Kingdom, SM2 5PT
- Royal Marsden - Surrey
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT12 6BE
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZG
- Royal Aberdeen Children's Hospital
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Edinburgh, Scotland, United Kingdom, EH9 1LF
- Royal Hospital for Sick Children
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Glasgow, Scotland, United Kingdom, G3 8SJ
- Royal Hospital for Sick Children
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Wales
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Cardiff, Wales, United Kingdom, CF14 4XW
- Childrens Hospital for Wales
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Best overall response (complete response and partial response)
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Secondary Outcome Measures
Outcome Measure |
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Death
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Early progression
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Disease progression or recurrence
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Surgical resection (complete or incomplete)
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Collaborators and Investigators
Investigators
- Study Chair: Jozsef Zsiros, MD, PhD, Emma Kinderziekenhuis
- Laurence Brugieres, MD, Gustave Roussy, Cancer Campus, Grand Paris
- Penelope Brock, MD, PhD, Great Ormond Street Hospital For Children NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Liver Diseases
- Neoplasms, Complex and Mixed
- Liver Neoplasms
- Hepatoblastoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- CDR0000454758
- CCLG-LT-2003-01
- CCLG-IRINOTECAN
- EU-20589
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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