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Last Modified: 11/20/2009     First Published: 9/24/2003  
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Phase II Study of Ecteinascidin 743 in Pediatric Patients With Recurrent or Refractory Soft Tissue Sarcomas or Ewing's Sarcoma Family of Tumors

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive1 to 21 (at time of diagnosis)NCICOG-ADVL0221
NCT00070109, ADVL0221

Objectives

  1. Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743.
  2. Determine the toxicity of this drug in these patients.
  3. Determine the pharmacokinetics of this drug in these patients.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed recurrent or refractory sarcomas, including the following:
    • Rhabdomyosarcoma
    • Nonrhabdomyosarcomatous soft tissue sarcoma
    • Ewing's sarcoma

  • Measurable disease by imaging studies
    • Lesions assessable only by radionuclide scans are not considered measurable
    • If the only measurable lesion has been previously irradiated, then that lesion must have shown evidence of an interim increase in size

  • No significant amount of metastatic liver disease, defined as the following:
    • Lesions occupying more than 25% of the liver by imaging and abnormal liver function tests or abnormal synthetic liver function

Prior/Concurrent Therapy:

Biologic therapy

  • More than 1 week since prior growth factors that support platelet or white blood cell number or function
  • At least 7 days since prior biologic agents and recovered
  • No prior allogeneic stem cell transplantation
  • No other concurrent immunomodulating agents

Chemotherapy

  • More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No more than 2 prior multi-agent chemotherapy regimens
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Concurrent steroids allowed

Radiotherapy

  • See Disease Characteristics
  • At least 6 weeks since prior since prior extended radiotherapy and recovered
  • No prior total body radiotherapy
  • Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated*

 [Note: *Any irradiated lesion cannot be used to assess tumor response]

Surgery

  • Not specified

Other

  • At least 7 days since prior enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin)
  • No concurrent enzyme-inducing anticonvulsants
  • No other concurrent investigational agents
  • No concurrent CYP3A4 inhibitors, including the following:
    • Grapefruit juice
    • Erythromycin
    • Azithromycin
    • Clarithromycin
    • Rifampin and its analogs
    • Fluconazole
    • Ketoconazole
    • Itraconazole
    • Cimetidine
    • Cannabinoids (marijuana or dronabinol)
    • Leukotriene inhibitors used in asthma (e.g., zafirlukast, montelukast, or zileuton)

Patient Characteristics:

Age

  • 21 and under (at time of diagnosis)

Performance status

  • Lansky 50-100% (10 years of age and under)
  • Karnofsky 50-100% (over 10 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 100,000/mm3 (transfusion independent)
  • Hemoglobin at least 8.0 g/dL (transfusion allowed)

Hepatic

  • See Disease Characteristics
  • Bilirubin no greater than upper limit of normal (ULN)
  • Total alkaline phosphatase no greater than ULN

    OR

  • Hepatic fraction alkaline phosphatase and 5 nucleotidase no greater than ULN
  • SGOT and SGPT normal for age
  • Albumin at least 2.5 g/dL

Renal

  • Maximum creatinine based on age as follows:
    • 0.8 mg/dL (5 years of age and under)
    • 1.0 mg/dL (6 to 10 years of age)
    • 1.2 mg/dL (11 to 15 years of age)
    • 1.5 mg/dL (over 15 years of age)

    OR

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min

Cardiovascular

  • No uncompensated congestive heart failure within the past 6 months

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 2 months after study participation
  • No active uncontrolled infection
  • Weight ≥ 15 kilograms

Expected Enrollment

60

A total of 30-60 patients (10-20 per stratum) will be accrued for this study within 2 years.

Outcomes

Primary Outcome(s)

Response rate

Secondary Outcome(s)

Toxicity
Pharmacokinetics

Outline

This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma family of tumors vs rhabdomyosarcoma vs nonrhabdomyosarcomatous soft tissue sarcoma).

Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Sylvain Baruchel, MD, Protocol chair
Ph: 416-813-7795

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Clinical Trials Office - UAB Comprehensive Cancer Center
Ph: 205-934-0309
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
California
  Downey
 Southern California Permanente Medical Group
 Robert Cooper
Ph: 323-783-5307
  Long Beach
 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
 Jerry Finklestein
Ph: 562-492-1062
  Los Angeles
 Childrens Hospital Los Angeles
 Leo Mascarenhas
Ph: 323-361-2529
 Jonsson Comprehensive Cancer Center at UCLA
 Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA
Ph: 888-798-0719
  Madera
 Children's Hospital Central California
 Vonda Crouse
Ph: 559-353-5480
  Orange
 Children's Hospital of Orange County
 Violet Shen
Ph: 714-532-8636
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  Stanford
 Stanford Cancer Center
 Clinical Trials Office - Stanford Cancer Center
Ph: 650-498-7061
 Email: cctoffice@stanford.edu
Colorado
  Aurora
 Children's Hospital Center for Cancer and Blood Disorders
 Kelly Maloney
Ph: 720-777-6673
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center
Ph: 800-579-7822
District of Columbia
  Washington
 Children's National Medical Center
 Clinical Trials Office - Children's National Medical Center
Ph: 202-884-2549
 Walter Reed Army Medical Center
 Clinical Trials Office - Walter Reed Army Medical Center
Ph: 202-782-7840
Florida
  Fort Myers
 Lee Cancer Care of Lee Memorial Health System
 Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System
Ph: 877-680-0008
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clinical Trials Office - Florida Hospital Cancer Institute
Ph: 407-303-5623
  St. Petersburg
 All Children's Hospital
 Gregory Hale
Ph: 727-767-4176
  Tampa
 St. Joseph's Cancer Institute at St. Joseph's Hospital
 Clinical Trials Office - St. Joseph's Cancer Institute
Ph: 800-882-4123
  West Palm Beach
 Kaplan Cancer Center at St. Mary's Medical Center
 Narayana Gowda
Ph: 561-844-6363
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Howard Katzenstein
Ph: 404-785-0853
Illinois
  Chicago
 Children's Memorial Hospital - Chicago
 Stewart Goldman
Ph: 773-880-3270
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center
Ph: 859-257-3379
  Louisville
 Kosair Children's Hospital
 Clinical Trials Office - Kosair Children's Hospital
Ph: 502-629-5500
 Email: CancerResource@nortonhealthcare.org
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Joseph Wiley
Ph: 410-601-5864
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Ph: 410-955-8804
 Email: jhcccro@jhmi.edu
Michigan
  Flint
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 David Dickens
Ph: 616-391-2086
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Clinical Trials Office - Children's Hospitals and Clinics of Minnesota
Ph: 612-813-5193
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail Megason
Ph: 601-984-5220
Missouri
  Kansas City
 Children's Mercy Hospital
 Maxine Hetherington
Ph: 816-234-3265
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert Hayashi
Ph: 314-454-4118
Nevada
  Las Vegas
 Jonathan Bernstein
Ph: 702-732-1493
 CCOP - Nevada Cancer Research Foundation
 Jonathan Bernstein
Ph: 702-732-0971
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Clinical Trials Office - Hackensack University Medical Center Cancer Center
Ph: 201-996-2879
  Morristown
 Overlook Hospital
 Hazem Mahmoud
Ph: 973-971-6720
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Albany
 Albany Medical Center Hospital
 Vikramjit Kanwar
Ph: 518-262-5513x25265
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine
Ph: 718-904-2730
 Email: aecc@aecom.yu.edu
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615
 Memorial Sloan-Kettering Cancer Center
 Peter Steinherz
Ph: 212-639-7951
 NYU Cancer Institute at New York University Medical Center
 Elizabeth Raetz
Ph: 212-263-8400
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Clinical Trials Office - Mission Hospitals - Memorial Campus
Ph: 828-213-4150
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Clinical Trials Office - Lineberger Comprehensive Cancer Center
Ph: 877-668-0683; 919-966-4432
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Akron
 Akron Children's Hospital
 Clinical Trials Office - Akron Children's Hospital
Ph: 330-543-3193
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 Clinical Trials Office - Cincinnati Children's Hospital Medical Center
Ph: 513-636-2799
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
 Rainbow Babies and Children's Hospital
 Yousif (Joe) Matloub
Ph: 216-844-3345
  Columbus
 Nationwide Children's Hospital
 Amanda Termuhlen
Ph: 614-722-3552
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene McNall-Knapp
Ph: 405-271-5311
Pennsylvania
  Hershey
 Penn State Cancer Institute at Milton S. Hershey Medical Center
 Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center
Ph: 717-531-3779
 Email: CTO@hmc.psu.edu
  Philadelphia
 Children's Hospital of Philadelphia
 Richard Aplenc
Ph: 267-426-7252
 St. Christopher's Hospital for Children
 Clinical Trials Office - St. Christopher's Hospital for Children
Ph: 215-427-8991
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina
Ph: 843-792-9321
  Columbia
 Palmetto Health South Carolina Cancer Center
 Clinical Trials Office - Palmetto Health South Carolina Cancer Center
Ph: 803-434-3680
  Greenville
 Greenville Hospital Cancer Center
 Clinical Trials Office - Greenville Hospital Cancer Center
Ph: 864-241-6251
Tennessee
  Knoxville
 East Tennessee Children's Hospital
 Ray Pais
Ph: 865-541-8266
  Memphis
 St. Jude Children's Research Hospital
 Clinical Trials Office - St. Jude Children's Research Hospital
Ph: 901-595-4644
Texas
  Austin
 Dell Children's Medical Center of Central Texas
 Clinical Trials Office - Dell Children's Medical Center of Central Texas
Ph: 512-324-8022
  Dallas
 Medical City Dallas Hospital
 Carl Lenarsky
Ph: 972-566-6647x4439
  Fort Worth
 Cook Children's Medical Center - Fort Worth
 Clinical Trials Office - Cook's Children's Medical Center
Ph: 682-885-2103
  Houston
 Baylor University Medical Center - Houston
 Patrick Thompson
Ph: 832-824-4029
Vermont
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Norfolk
 Children's Hospital of The King's Daughters
 Eric Lowe
Ph: 757-668-7243
  Roanoke
 Carilion Medical Center for Children at Roanoke Community Hospital
 Mandy Atkinson
Ph: 540-981-7376
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Julie Park
Ph: 206-987-2106
Wisconsin
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Michael Kelly
Ph: 414-456-4170
Canada
  Quebec
 Centre Hospitalier Universitaire de Quebec
 Bruno Michon
Ph: 418-656-4141X47191
British Columbia
  Vancouver
 Children's & Women's Hospital of British Columbia
 Mason Bond
Ph: 604-875-2322
Nova Scotia
  Halifax
 IWK Health Centre
 Margaret Yhap
Ph: 902-470-8778
Ontario
  Hamilton
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine
Ph: 905-521-2100x73464
  Ottawa
 Children's Hospital of Eastern Ontario
 Jacqueline Halton
Ph: 613-737-7600x2370
  Toronto
 Hospital for Sick Children
 Sylvain Baruchel
Ph: 416-813-7795
Quebec
  Montreal
 Yvan Samson
Ph: 514-345-4969
 Hopital Sainte Justine
 Yvan Samson
Ph: 418-656-4141x47191

Registry Information
Official Title A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcoma
Trial Start Date 2008-01-28
Trial Completion Date 2010-09-01 (estimated)
Registered in ClinicalTrials.gov NCT00070109
Date Submitted to PDQ 2003-08-14
Information Last Verified 2009-11-23
NCI Grant/Contract Number CA98543

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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