A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
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.
Interventional
Primary Purpose: Treatment
Albert Moghrabi, MD
Study Chair
Hopital Sainte Justine
United States: Federal Government
CDR0000068410
NCT00008424
October 2000
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - Green Bay | Green Bay, Wisconsin 54301 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's Hospital of Denver | Denver, Colorado 80218 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
Mott Children's Hospital | Ann Arbor, Michigan 48109-0914 |
Columbia Presbyterian Hospital | New York, New York 10032 |
Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Children's Memorial Hospital, Chicago | Chicago, Illinois 60614 |