Malignant Mesothelioma Clinical Trial
Official title:
A Second-line, Single Arm, Phase II Clinical Study With Tremelimumab, a Fully Human Anti-CTLA-4 Monoclonal Antibody as Monotherapy in Patients With Unresectable Malignant Mesothelioma
The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.
Status | Active, not recruiting |
Enrollment | 29 |
Est. completion date | June 2013 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed malignant mesothelioma (MM) - Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM - 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 - Not pregnant or nursing - 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 Exclusion Criteria: - Symptomatic chronic inflammatory or autoimmune disease - Active hepatitis B or C - 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 not 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 - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Medical Oncology and Immunotherapy Unit, University Hospital of Siena | Siena |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Senese |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective tumor response by modified Response Evaluation Criteria in Solid Tumor (RECIST) | The objective tumor response is defined as a confirmed complete response (CR) or partial response (PR) according to the modified RECIST criteria for pleural mesothelioma | Weeks 24 | No |
Secondary | Disease control rate | Disease control rate (DCR) is the proportion of treated subjects that achieved confirmed complete response, or partial response, or stable disease. The DCR is assessed using the modified RECIST criteria for pleural mesothelioma |
1 year | No |
Secondary | Progression free survival | Progression free survival is computed from the first day of study treatment to the day of documented progression according to the modified RECIST criteria for pleural mesothelioma or death, whichever occurs first | 1 year | No |
Secondary | Safety | The assessment of safety includes serious and non-serious adverse events according to NCI-CTC criteria version 3.0. In addition, laboratory evaluation, abnormal vital signs and physical examination findings are also included. | 2 years | Yes |
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