MESOT-TREM-2012
- Conditions
- Patients affected by advanced malignant mesotheliomaMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10035603Term: Pleural mesotheliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002762-12-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the rate of objective clinical complete response (CR) or partial response (PR);Secondary Objective: 1) To define toxicity profile <br>2) To assess the OS<br>3) To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) <br>4) To assess the progression-free survival in treated patients<br>5) To evaluate qualitative and quantitative changes in cellular and humoral immune responses;Primary end point(s): To assess the rate of objective clinical complete response (CR) or partial response (PR);Timepoint(s) of evaluation of this end point: 30 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) To define toxicity profile <br>2) To assess the OS<br>3) To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) <br>4) To assess the progression-free survival in treated patients<br>5) To evaluate qualitative and quantitative changes in cellular and humoral immune responses;Timepoint(s) of evaluation of this end point: 30 mouths