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

Brief Title

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

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Antitumor activity defined as progression free survival (PFS)

Secondary Outcome

 Tumor Growth Control Rate (TGCR)

Condition

Malignant Pleural Mesothelioma

Intervention

NGR-hTNF

Study Arms / Comparison Groups

 NGR-hTNF

Description:  NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

57

Start Date

May 2007

Completion Date

March 2013

Primary Completion Date

March 2013

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Antonio Lambiase, MD, , 

Location Countries

Italy

Location Countries

Italy

NCT ID

NCT00484276

Organization ID

NGR010

Secondary IDs

2006-005993-39

Responsible Party

Sponsor

Study Sponsor

AGC Biologics S.p.A.

Study Sponsor

Antonio Lambiase, MD, Study Director, AGC Biologics S.p.A.

Verification Date

January 2019