Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of
ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the
pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of
this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to
pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV
over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting
toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
Interventional
Primary Purpose: Treatment
Sylvain Baruchel, MD
Study Chair
The Hospital for Sick Children
United States: Federal Government
CDR0000068273
NCT00006463
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 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
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 |
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 Cancer Center | Nashville, Tennessee 37232-6838 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
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 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 |