IRB #

IRB00001666

Title

A Multicenter, Open-Label Single-Arm Study of YONDELIS (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Excluding Leiomyosarcoma and Liposarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment

Principal Investigator

Christopher Ryan

Study Purpose

The purpose of this study is to determine if the study vaccine in combination with OPT-821 works better then OPT-821 alone in preventing reccrurance of patient's metastic soft tissue sarcoma.

Medical Condition(s)

Soft Tissue

Eligibility Criteria

* Subject's must have stage IV sarcoma with either newly dianosed or distant relapsed disease
* Subject's must have had surgical mastectomy within 8 weeks of starting treatment that rendered them radiographically disease free
*Subject's with locally recurrant disease only are not eligible
* Subject's must be 16 or older

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Approximately 4 months on average

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

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

Recruitment End

Compensation Provided

No