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Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma (NGR010)

This study is currently recruiting participants.
Verified by MolMed S.p.A., May 2008

Sponsored by: MolMed S.p.A.
Information provided by: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00484276
  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.


Condition Intervention Phase
Mesothelioma
Drug: NGR-hTNF
Phase II

MedlinePlus related topics:   Mesothelioma   

U.S. FDA Resources

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 or Weekly 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) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor Growth Control Rate (TGCR) according to RECIST criteria • Overall survival (OS) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Estimated Enrollment:   39
Study Start Date:   May 2007
Estimated Study Completion Date:   October 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: NGR-hTNF
    iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
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.

  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 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484276

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    
  More Information


Responsible Party:   Molmed ( Molmed )
Study ID Numbers:   NGR010, EUDRACT Number: 2006-005993-39
First Received:   June 7, 2007
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00484276
Health Authority:   Italy: National Institute of Health

Keywords provided by MolMed S.p.A.:
NGR-hTNF  
malignant pleural mesothelioma  

Study placed in the following topic categories:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on November 20, 2008




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