Clinical Trials for Mesothelioma Patients: Study of NGR-hTNF

Read the inclusion criteria for this current clinical trial being conducted to study the effects of NGR-hTNF for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. At this time, the study is currently being conducted only in Milan, Italy.

Inclusion Criteria:
Patients >18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen

Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed

Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy

ECOG Performance status 0 – 2

Adequate baseline bone marrow, hepatic and renal function, defined as follows:

Neutrophils > 1.5 x 109/L and platelets > 100 x 109/L

Bilirubin < 1.5 x ULN

AST and/or ALT < 2.5 x ULN in absence of liver metastasis

AST and/or ALT < 5 x ULN in presence of liver metastasis

Serum creatinine < 1.5 x ULN
Absence of any conditions in which hypervoleamia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference “Technical data sheet human albumin” specifically used in Pharmacy Department for NGR-hTNF dilution)

Patients may have had prior therapy providing the following conditions are met:

Chemotherapy and radiotherapy: wash-out MolMed S.p.A. CLINICAL STUDY PROTOCOL Internal Code: IPR/16.B Confidential page 3 of 50 period of 28 days
Surgery: wash-out period of 14 days
Normal cardiac function and absence of uncontrolled hypertension
Patients must give written informed consent to participate in the study

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