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A Phase II Study of Trabectedin in Children with Recurrent Rhabdomyosarcoma, Ewing's Sarcoma, or Nonrhabdomyosarcomatous Sarcomas

[Protocol 08-145]

Full Title :

A PHASE II STUDY OF TRABECTEDIN (ET-743, YONDELIS) IN CHILDREN WITH RECURRENT RHABDOMYOARCOMA, EWING SARCOMA, OR NONRHABDOMYOSARCOMATOUS SOFT TISSUE SARCOMAS (COG# ADVL0221)

Purpose :

The purpose of this study is to evaluate the safety and effectiveness of an investigational agent called trabectedin in children with recurrent rhabdomyosarcoma, Ewing's sarcoma, or nonrhabdomyosarcomatous sarcomas.

Trabectedin is an agent isolated from a sea sponge. It appears to work against cancer cells by binding to their DNA and interfering with their ability to grow and divide. Prior studies have indicated that trabectedin has activity against certain types of sarcoma.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of recurrent rhabdomyosarcoma, Ewing's sarcoma, or nonrhabdomyosarcomatous sarcomas.
• Patients must have recovered from the side effects of all prior therapies.
• Patients may not have received prior total body irradiation or an allogeneic stem cell transplant.
• Patients must be between the ages of 1 and 21 (inclusive).

For more information and to inquire about eligibility for this study, please contact Dr. Leonard H. Wexler at 212-639-7990.