Clinical trial · Interventional
Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
NCT00287976CI-TRIAL-00012139unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Best overall response (complete response and partial response)
Secondary outcomes (4)
- measure
- Early progression
- measure
- Death
- measure
- Disease progression or recurrence
- measure
- Surgical resection (complete or incomplete)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.