Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
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|ClinicalTrials.gov Identifier: NCT00579501|
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : March 11, 2014
Last Update Posted : May 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Liposarcoma,Myxoid||Drug: Trabectedin Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.
Trabectedin 1.5 mg/m^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.
Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
- Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. ]Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.
- Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. ]The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579501
|United States, Idaho|
|Coeur D Alene, Idaho, United States|
|United States, Illinois|
|Park Ridge, Illinois, United States|
|United States, Iowa|
|Iowa City, Iowa, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|