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

Article Tools:

In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Recruiting
Sponsors and Collaborators: MolMed S.p.A.
Information provided by: MolMed S.p.A.
Government Identifier: NCT00484276

Condition: Mesothelioma
Intervention: Drug: NGR-hTNF

    - Return To Top

Purpose:


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

Further study details as provided by MolMed S.p.A.:

Primary Outcome Measures:
  • Antitumor activity defined as progression free survival (PFS)

Secondary Outcome Measures:
  • • Tumor Growth Control Rate (TGCR) according to RECIST criteria • Overall survival (OS)

Estimated Enrollment: 27
Study Start Date: May 2007
Estimated Study Completion Date: October 2008

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.

    - Return To Top

Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 109/L and platelets > 100 x 109/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 hypervoleamia 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 MolMed S.p.A. CLINICAL STUDY PROTOCOL Internal Code: IPR/16.B Confidential page 3 of 50 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

    - Return To Top

Contacts and Locations:

Contacts
Contact: Federico Caligaris-Cappio, MD +39 02 2643 ext 2529
Locations
Italy
Istituto Europeo Oncologico Recruiting
Milan, Italy
Italy, Milan
Istituto Clinico Humanitas Recruiting
Rozzano, Milan, Italy

Sponsors and Collaborators
MolMed S.p.A.

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

    - Return To Top

Additional Information:

Study ID Numbers:   NGR010
First Received:   June 7, 2007
Last Updated:   June 7, 2007
ClinicalTrials.gov Identifier:   NCT00484276
Health Authority:   Italy: National Institute of Health

Keywords provided by MolMed S.p.A.:
NGR-hTNF  
malignant pleural mesothelioma  
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 placed in the following topic categories:
Disease Progression
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Mesothelioma
Neoplasms, Mesothelial

    - Return To Top

Free case consultation

If you or a loved one has been diagnosed with mesothelioma or another asbestos-related disease, contact us using the form below to speak with a mesothelioma consultant, free of charge.