Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00008424
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerable dose (MTD) of irinotecan
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (41 remaining)University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States