Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00287976
First received: February 6, 2006
Last updated: July 1, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Best overall response (complete response and partial response) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Early progression [ Designated as safety issue: No ]
- Death [ Designated as safety issue: No ]
- Disease progression or recurrence [ Designated as safety issue: No ]
- Surgical resection (complete or incomplete) [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2003 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287976
Locations
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| Netherlands | |
| Emma Kinderziekenhuis | |
| Amsterdam, Netherlands, NL-1100 DE | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| Royal London Hospital | |
| London, England, United Kingdom, E1 1BB | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
| Study Chair: | Jozsef Zsiros, MD, PhD | Emma Kinderziekenhuis |
| Investigator: | Laurence Brugieres, MD | Institut Gustave Roussy |
| Investigator: | Penelope Brock, MD, PhD | Great Ormond Street Hospital for Children NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00287976 History of Changes |
| Other Study ID Numbers: | CDR0000454758, CCLG-LT-2003-01, CCLG-IRINOTECAN, EU-20589 |
| Study First Received: | February 6, 2006 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
childhood hepatoblastoma recurrent childhood liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Hepatoblastoma Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Irinotecan Camptothecin |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013