Official Title: “NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Drug: NGR-hTNF
  • iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Primary Measures

• • Antitumor activity defined as progression free survival (PFS)
  • Time Frame: during the study
    Safety Issue?: No

Secondary Measures

• • Tumor Growth Control Rate (TGCR) according to RECIST criteria • Overall survival (OS)
  • Time Frame: during the study
    Safety Issue?: No
• • Experimental Imaging Study (DCE-MRI)
  • Time Frame: During the treatment
    Safety Issue?: No
• • Pharmacokinetics in patients treated with weekly schedule
  • Time Frame: During the treatment
    Safety Issue?: No
• •Safety
  • Time Frame: During the treatment and during the follow-up
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MolMed S.p.A.

Overall Clinical Trial Officials and Contacts

Federico Caligaris Cappio, MD Principal Investigator Fondazione San Raffaele del Monte Tabor  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00484276

Study ID Number: NGR010

ClinicalTrials.gov Identifier: NCT00484276

Health Authority: Italy: National Institute of Health