Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
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|ClinicalTrials.gov Identifier: NCT00287976|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 7, 2006
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: irinotecan hydrochloride||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma|
|Study Start Date :||April 2003|
|Estimated Primary Completion Date :||December 2008|
- Best overall response (complete response and partial response)
- Early progression
- Disease progression or recurrence
- Surgical resection (complete or incomplete)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287976
|Study Chair:||Jozsef Zsiros, MD, PhD||Emma Kinderziekenhuis|
|OverallOfficial:||Laurence Brugieres, MD||Gustave Roussy, Cancer Campus, Grand Paris|
|OverallOfficial:||Penelope Brock, MD, PhD||Great Ormond Street Hospital for Children NHS Foundation Trust|