This trial is active, not recruiting.

Condition liver cancer
Treatment irinotecan hydrochloride
Phase phase 2
Sponsor Children's Cancer and Leukaemia Group
Start date April 2003
End date December 2008
Trial size 30 participants
Trial identifier NCT00287976, CCLG-IRINOTECAN, CCLG-LT-2003-01, CDR0000454758, EU-20589


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Best overall response (complete response and partial response)
time frame:

Secondary Outcomes

Early progression
time frame:
time frame:
Disease progression or recurrence
time frame:
Surgical resection (complete or incomplete)
time frame:

Eligibility Criteria

Male or female participants up to 20 years old.

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

Additional Information

Official title Irinotecan Single-Drug Treatment For Children 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).