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

Completed · Phase 2

Conditions studied: Liposarcoma,Myxoid

In brief

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).

Key facts

Study ID

NCT00579501

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

29

Starts

2007-04-01

Expected to finish

2010-01-01

Last updated by the study team

2014-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
• Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
• Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])
• No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

You may not qualify if…

• Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone
• Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods
• History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
• Known distant metastases
• Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias

Where it is running

• Study site — Coeur d'Alene, Idaho, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Boston, Massachusetts, United States
• Study site — Bourdeaux, France
• Study site — Lyon, France
• Study site — Villejuif, France
• Study site — Mannheim, Germany

Full record on ClinicalTrials.gov

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