The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using Simon's two-stage design method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Fondazione San Raffaele del Monte Tabor
Milan, Italy
Istituto Europeo Oncologico
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Antitumor activity defined as progression free survival (PFS)
Defined as the time from the date of randomization until disease progression, or death
Time frame: during the study
Tumor Growth Control Rate (TGCR)
Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma
Time frame: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD
Overall survival (OS)
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Time frame: from the randomization until to the date of patient death or discontinuation from the study
Experimental Imaging Study (DCE-MRI)
To document possible modifications on vessels permeability by imaging techniques
Time frame: During the treatment
Cmax of NGR-hTNF in patients treated with weekly schedule
to evaluate Cmax of NGR-hTNF administered weekly
Time frame: During the treatment
AUC(tau) of NGR-hTNF in patients treated with weekly schedule
to evaluate AUC(tau) of NGR-hTNF administered weekly
Time frame: During the treatment
Safety according to NCI-CTCAE criteria (version 3)
To evaluate safety profile related to NGR-hTNF
Time frame: During the treatment and during the follow-up
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