The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma
Conditions
Malignant Mesothelioma
Conditions: official terms
Lung Neoplasms - Mesothelioma
Conditions: Keywords
Tremelimumab, anti-CTLA-4 monoclonal antibody, malignant mesothelioma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Tremelimumab
Type: Drug
Overall Status
Recruiting
Summary
RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients.

PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression.
Detailed Description
Primary endpoint:

1) To assess the rate of objective clinical complete response (CR) or partial response (PR)

Secondary endpoints:

1. To define toxicity profile according to NCI CT-CAE V. 3

2. To assess the overall survival (OS)

3. To estimate disease control rate (DCR) (proportion of patients with best response of CR+PR+SD) according to the modified Recist criteria

4. To assess the progression-free survival in treated patients according to modified Recist criteria

5. To evaluate qualitative and quantitative changes in cellular and humoral immune responses
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically or cytologically confirmed MM

- Have received only one prior systemic chemotherapy platinum-based 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 (modified 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 > 75000/mm3

- Absolute granulocyte count > 1000/mm3

- Hemoglobin > 9 g/dL

- Bilirubin total < 1.5 x ULN (Upper limited normal), except patients with documented Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dl

- AST and ALT < 2.5 x ULN ( < 5 x ULN if documented liver metastasis are present)

- Creatinine level < 2mg/dl or calculated creatinine clearance > 60 mL/min as determined by the Cockcroft Gault equation.

- 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

Exclusion Criteria:

- Symptomatic chronic inflammatory or autoimmune disease

- Active hepatitis B or C

- Prior treatment with tremelimumab or other anti-CTLA-4 antibody or anti-PD1, anti-PDL-1 agents

- Clinically relevant cardiovascular disease

- 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
Location
Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Siena, Italy
Status: Recruiting
Contact: Michele Maio, MD - +39-0577586335 - mmaio@cro.it
Start Date
July 2012
Completion Date
January 2015
Sponsors
Azienda Ospedaliera Universitaria Senese
Source
Azienda Ospedaliera Universitaria Senese
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page