Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma|
- 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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2007|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.Drug: Dexamethasone
Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.
|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.|