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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00287976
First received: February 6, 2006
Last updated: September 16, 2013
Last verified: June 2009
  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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Gustave Roussy, Cancer Campus, Grand Paris
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: September 16, 2013
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014