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)
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Columbia Presbyterian Hospital
🇺🇸New York, New York, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
McGill University Health Center - Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
CCOP - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States