A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcomas
I. 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
II. Determine the toxicity of this drug in these patients. III. Determine the
pharmacokinetics of this drug in these patients.
Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 21days for up
to 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response [CR] and partial response [PR]) using the Response Evaluation Criteria in Solid Tumors (RECIST)
Response rates and confidence intervals will be constructed according to the method of Chang and O'Brien. All patients who have two consecutive evaluations of stable disease, CR, or PR must have imaging studies reviewed centrally at the Children Oncology Group (COG).
Up to 5 years after completion of study treatment
Children's Oncology Group
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Children's Hospital Central California||Madera, California 93638-8762|
|Nationwide Children's Hospital||Columbus, Ohio 43205-2696|
|University Of Vermont||Burlington,, Vermont 05403|
|Seattle Children's Hospital||Seattle, Washington 98105|
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|
|Childrens Memorial Hospital||Chicago, Illinois 60614|
|New York University Langone Medical Center||New York, New York 10016|
|Columbia University Medical Center||New York, New York 10032|