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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Trabectedin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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