Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

Liver Cancer Clinical Trial

Official title:

Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00287976
• Other study ID #: CDR0000454758
• Secondary ID: CCLG-LT-2003-01C
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 6, 2006
• Last updated: September 16, 2013
• Start date: April 2003

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatoblastoma
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children Crumlin	Dublin
Netherlands	Emma Kinderziekenhuis	Amsterdam
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	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	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
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	Great Ormond Street Hospital for Children	London	England
United Kingdom	Royal London Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall response (complete response and partial response)			No
Secondary	Early progression			No
Secondary	Death			No
Secondary	Disease progression or recurrence			No
Secondary	Surgical resection (complete or incomplete)			No