Malignant Pleural Mesothelioma
Conditions
Keywords
NGR-hTNF, malignant pleural mesothelioma
Brief summary
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.
Detailed description
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.
Interventions
DRUGNGR-hTNF
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Sponsors
AGC Biologics S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 10\^9/L and platelets \> 100 x 10\^9/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
Exclusion criteria
* Concurrent anticancer therapy * Patients may not receive any other investigational agents while on study * Clinical signs of CNS involvement * Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor activity defined as progression free survival (PFS) | during the study | Defined as the time from the date of randomization until disease progression, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(tau) of NGR-hTNF in patients treated with weekly schedule | During the treatment | to evaluate AUC(tau) of NGR-hTNF administered weekly |
| Tumor Growth Control Rate (TGCR) | Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD | Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma |
| Safety according to NCI-CTCAE criteria (version 3) | During the treatment and during the follow-up | To evaluate safety profile related to NGR-hTNF |
| Experimental Imaging Study (DCE-MRI) | During the treatment | To document possible modifications on vessels permeability by imaging techniques |
| Cmax of NGR-hTNF in patients treated with weekly schedule | During the treatment | to evaluate Cmax of NGR-hTNF administered weekly |
| Overall survival (OS) | from the randomization until to the date of patient death or discontinuation from the study | 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 |
Countries
Italy
Outcome results
None listed