Trial | NCT00287976  Report issue

Title

Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    irinotecan ...

  • Study Participants

    30
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.
Study Started
Apr 30
2003
Primary Completion
Dec 31
2008
Anticipated
Last Update
Sep 17
2013
Estimate

Drug irinotecan hydrochloride

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
No Results Posted