Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma

Launched by AGC BIOLOGICS S.P.A. · Jun 7, 2007

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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