Clinical Trials for Mesothelioma Patients: NGR-hTNF as Single Agent Inclusion Criteria

Read about the inclusions criteria for a current clinical trial being conducted to study NGR-hTNF as a single agent in patients who have been diagnosed with mesothelioma. At this time, the study is only being conducted in Italy. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

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 hypervolemia 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 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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