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

February 6, 2006
September 16, 2013
April 2003
December 2008   (final data collection date for primary outcome measure)
Best overall response (complete response and partial response) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00287976 on ClinicalTrials.gov Archive Site
  • 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 ]
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Not Provided
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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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
Drug: irinotecan hydrochloride
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
December 2008   (final data collection date for primary outcome measure)

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
Both
up to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   Netherlands,   United Kingdom
 
NCT00287976
CDR0000454758, CCLG-LT-2003-01, CCLG-IRINOTECAN, EU-20589
Not Provided
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Children's Cancer and Leukaemia Group
Not Provided
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
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP