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

Phase 2
18 Years
Not Enrolling
Liposarcoma, Myxoid, Round Cell Component

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Trial Information

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

Trabectedin will be administered 1.5 mg/m2 intravenously over 24 hours every three weeks.
Patients will be assessed weekly by physical exam and / or laboratory testing. Radiological
examination will occur every 6 weeks to evaluate the patient's disease. Patients
participating in this study will undergo a surgery after the completion of the treatment in
order to remove all the detectable disease and to find out if a pathologic complete response
has occurred. Pathological complete response means that with surgery or biopsy no cancer is
found. In this study, patients whose disease has not progressed at the end of the
neoadjuvant treatment will be followed every 6 weeks until progression, 6 months post
definitive surgery or until resolution of any drug-related adverse events (AEs) and
sequelae. Trabectedin will be given at 1.5 mg/m2 over a 24-hour intravenous infusion every 3
weeks for a minimum of 3 and a maximum of 6 cycles of neoadjuvant trabectedin in the absence
of overt disease progression, unmanageable toxicity, patient refusal or treatment delay
longer than 3 weeks for toxicity (except in case of obvious patient benefit).Dexamethasone,
20mg, iv, will be administered within 30 minutes before start of each trabectedin iv

Inclusion Criteria:

- 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

- No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)

Exclusion Criteria:

- Known hypersensitivity to any of the components of the trabectedin

- Pregnant or lactating women or men 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective pathological complete response (CR) rate

Outcome Time Frame:

Up to approximately 18 months

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

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


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

January 2010

Related Keywords:

  • Liposarcoma, Myxoid, Round Cell Component
  • Myxoid
  • Liposarcoma
  • Round Cell component
  • Liposarcoma
  • Liposarcoma, Myxoid