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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00484276
First received: June 7, 2007
Last updated: May 29, 2014
Last verified: May 2014
  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
Malignant Pleural Mesothelioma
Drug: NGR-hTNF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]
  • • Experimental Imaging Study (DCE-MRI) [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
  • • Pharmacokinetics in patients treated with weekly schedule [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
  • •Safety [ Time Frame: During the treatment and during the follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: May 2007
Study Completion Date: April 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Istituto Europeo Oncologico
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Fondazione San Raffaele del Monte Tabor
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Study Director: Antonio Lambiase, MD MolMed S.p.A.
  More Information

Publications:
Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00484276     History of Changes
Other Study ID Numbers: NGR010, EUDRACT Number: 2006-005993-39
Study First Received: June 7, 2007
Last Updated: May 29, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on July 23, 2014