Clinical Trial Details

NCT ID: NCT01655888
Date Last Changed: July 31, 2012

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Malignant Mesothelioma

Research Study 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 MESOT-TREM-2012

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Azienda Ospedaliera Universitaria Senese
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
Italy Siena 53100 Medical Oncology and Immunotherapy Unit, University Hospital of Siena
Michele Maio, MD
+39-0577586335
mmaio@cro.it

Michele Maio, MD
Principal Investigator

Luana Calabrò, MD
Sub-Investigator

Contact

Michele Maio, MD
+39-0577586335
E-mail:

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