Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
- Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00006463
- 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. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ECTEINASCIDIN 743 (1300 ug/m2) ECTEINASCIDIN 743 - Therapy ECTEINASCIDIN 743 (1100 ug/m2 ) ECTEINASCIDIN 743 -
- Primary Outcome Measures
Name Time Method Progression Free Survival Length of study
- Secondary Outcome Measures
Name Time Method Dose Limiting Toxicity To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
Determine a safe and tolerable dose of vincristine, when administered with irinotecan To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
Determine the pharmacokinetics of vincristine and irinotecan Length of study To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
Determine the incidence and severity of other toxicities Length of study To determine the incidence and severity of other toxicities of this combination.
Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine Length of study To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
Trial Locations
- Locations (47)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, 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 of Orange County
🇺🇸Orange, California, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Columbia Presbyterian Hospital
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada