Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
NCT ID: NCT00006463
Last Updated: 2014-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2000-10-31
2005-09-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
ECTEINASCIDIN 743
ECTEINASCIDIN 743 (1300 ug/m2)
ECTEINASCIDIN 743
Interventions
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ECTEINASCIDIN 743
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky 50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater than grade II
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 1 week since prior growth factor therapy At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not specified Other: No concurrent foods or medication that interferes with P-450 metabolism Anticonvulsants allowed
1 Year
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Sylvain Baruchel, MD
Role: STUDY_CHAIR
The Hospital for Sick Children
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, 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
Beckman Research Institute, City of Hope
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 National Medical Center
Washington D.C., District of Columbia, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Columbia Presbyterian Hospital
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
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
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Countries
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References
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Lau L, Supko JG, Blaney S, Hershon L, Seibel N, Krailo M, Qu W, Malkin D, Jimeno J, Bernstein M, Baruchel S. A phase I and pharmacokinetic study of ecteinascidin-743 (Yondelis) in children with refractory solid tumors. A Children's Oncology Group study. Clin Cancer Res. 2005 Jan 15;11(2 Pt 1):672-7.
Other Identifiers
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COG-P9972
Identifier Type: OTHER
Identifier Source: secondary_id
POG-P9972
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068273
Identifier Type: OTHER
Identifier Source: secondary_id
P9972
Identifier Type: -
Identifier Source: org_study_id
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