CIRB Approved Protocols
COG-ADVL0221
Lead Group:
COG
"A Phase II Study of ET-743 in Children with Recurrent Sarcomas"
2/24/2005 1/28/2008 1/20/2009
http://www.cancer.gov/clinicaltrials/COG-ADVL0221
Expected Enrollment
60
A total of 30-60 patients (10-20 per stratum) will be accrued for this study within 2 years.
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.
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
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
Registered in ClinicalTrials.gov NCT00070109
Date Submitted to PDQ 2003-08-14
Information Last Verified 2008-02-01
NCI Grant/Contract Number CA98543