Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
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|ClinicalTrials.gov Identifier: NCT00008424|
Recruitment Status : Completed
First Posted : June 5, 2003
Last Update Posted : May 5, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride||Phase 1|
- Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants.
- Determine the dose-limiting toxicity of irinotecan in this patient population.
- Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.
- Determine, preliminarily, the antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants).
Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months for up to 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Official Title:||A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||September 2006|
- Maximum tolerable dose (MTD) of irinotecan
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): NCT00008424
|Study Chair:||Albert Moghrabi, MD||Hopital Sainte Justine|