Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: Camptothecin; Irinotecan

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