A multicenter Phase II clinical trial of neoadjuvant trabectedin (Yondelis) in patients with localized myxoid / round cell liposarcoma. - ND
- Conditions
- ocalized myxoid / round cell liposarcoma (MRCL).MedDRA version: 6.1Level: PTClassification code 10024630
- Registration Number
- EUCTR2007-000035-25-IT
- Lead Sponsor
- PHARMA MAR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 22
PatientŽs written informed consent before any study-specific procedure Adult patients (more than or equal to 18 years)
Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
Clinical evidence of localized, non-metastatic tumor, including locally recurring disease after initial surgery
Measurable disease (by RECIST)
No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Hematologic variables:
oHemoglobin more than or equal to 9 g/dL
oAbsolute neutrophil count (ANC)more than or equal to 1,500/µL, and oPlatelet count more than or equal to 100,000/µL
Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance more than or equal to 30 mL/min
Creatinine phosphokinase (CPK) less than or equal to 2.5 ULN
Hepatic function variables:
oTotal bilirubin less than or equal to ULN
oTotal alkaline phosphatase less than or equal to 2.5 ULN, or if > 2.5 ULN consider alkaline phosphatase liver fraction or GGT or 5? nucleotidase must be less than or equal to ULN
o AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be less than or equal to 2.5 x ULN
Albumin more than or equal to 25 g/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone
Pregnant or lactating women or any patient of childbearing potential who are not employing adequate contraception
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
Psychiatric disorder that prevents compliance with protocol
Active viral hepatitis or chronic liver disease
Active infection
Any other unstable medical condition
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the pathological complete response (pCR) rate with trabectedin in patients with localized myxoid / round cell liposarcoma (MRCL).;Secondary Objective: Evaluate the objective response rate by RECIST and contrast such response with changes in radiological density and tumor pathology. Describe the incidence and severity of adverse events in this patient population. Exploratory, hypothesis-generating pharmacogenomic analyses to correlate molecular parameters in patient samples with clinical outcomes (pCR).;Primary end point(s): The primary efficacy evaluation will be the central assessment of pathological response in the surgical specimen.
- Secondary Outcome Measures
Name Time Method