Clinical Trial: Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: 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.


Original Primary Outcome: To determine the pathological complete response (pCR) rate with trabectedin in patients with localized myxoid / round cell liposarcoma (MRCL)

Current Secondary Outcome: 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.


Original Secondary Outcome: Evaluate the objective response rate by RECIST and contrast such response with changes in radiological density and tumor pathology Describe the incidence and severity of adverse events in this patient population

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: December 20, 2007
Date Started: April 2007
Date Completion:
Last Updated: April 22, 2014
Last Verified: April 2014