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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Liposarcoma,Myxoid

Treatments: Drug: Dexamethasone; Drug: Trabectedin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00579501

ET-B-028-06 (Other Identifier)

CR014767

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Trabectedin

Experimental group

Description:

Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.

Treatment:

Drug: Dexamethasone

Drug: Trabectedin