A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMANIZED ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA - MESOT-TREM-2012

AZIENDA OSPEDALIERA SENESE0 个研究点开始时间: 2012年8月3日最近更新: 2016年3月14日

试验速览

暂无简介。

•Histologically or cytologically confirmed MM
•Have received only one prior systemic chemotherapy regimen for advanced MM
•Measurable disease, defined at least 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (RECIST criteria).
•Disease not amenable to curative surgery
•No known brain metastasis
•Age 18 and over
•Performance status 0-2
•Life expectancy > 12 weeks
•Adequate hematologic, hepatic and renal function
•Platelet count > 100000/mm3
•Absolute granulocyte count > 1500/mm3
•Hemoglobin > 9 g/dL
•Bilirubin total < 2 x ULN (Upper limited normal)
•AST and ALT < 2.5 x ULN (< 5 x ULN if documented liver metastasis are present)
•Creatinine level < 2mg/dl or creatinine clearance > 50 mL/min
•Not pregnant or nursing
•Fertile patients must use effective contraception
•Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 9

•Symptomatic chronic inflammatory or autoimmune disease
•Active hepatitis B or C
•Prior treatment with tremelimumab or other anti-CTLA-4 antibody
•Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more
•History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
•Uncontrolled active infections
•Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study
•Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
•History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years

发起方

AZIENDA OSPEDALIERA SENESE