A Multicenter, Open-Label, Single-Arm Study of YONDELIS (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment Save

Date Added
October 5th, 2009
IRB Number
15603
Researcher
Daniel Reuben
Keywords
Cancer, Cancer/Sarcoma, Drug Studies
Summary

The purpose of this study is to provide an experimental drug called Yondelis to eligible patients who have not responded to previous treatment. This drug has not been approved for sale by the FDA for use with your type of cancer. Safety evaluation of this drug will also occur during this study that will include physical exams, monitoring of your vital signs and side effects, and performing laboratory tests.

Patients who participate in this study will receive Yondelis as a 24-hour infusion. You may be hospitalized only for the first cycle of this treatment. You will receive treatment on day 1 of every 17 to 49 day cycle. You will visit your doctor on day 1 of each cycle and blood will be taken during the middle of each cycle and at the end of treatment.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
brisend@musc.edu

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