A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419328
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : January 29, 2013
Information provided by:
MolMed S.p.A.

Brief Summary:
The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: NGR-hTNF Phase 1

Detailed Description:
This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced solid tumors for the definition of an optimal biological

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose
Study Start Date : March 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: A Drug: NGR-hTNF
iv q3W escalating dose up 1.6 mcg/sqm

Primary Outcome Measures :
  1. To verify safety of escalating doses of NGR-hTNF [ Time Frame: during and following the treatment ]

Secondary Outcome Measures :
  1. To document possible modifications on vessels permeability [ Time Frame: before and following the first treatment ]
  2. To document signs of anticancer activity [ Time Frame: every 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients >18 years old with proven advanced solid tumors not amenable to any clinical improvement by current standard treatments. Tumors recognized to be highly vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included.
  • ECOG Performance status 0 - 2
  • Patients may have had prior therapy providing the following conditions are met:

    • Chemo, radio, hormonal or immunotherapy: wash-out period of 28 days
    • Surgery: wash-out period of 14 days
  • 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 metastases
  • AST and/or ALT < 5 x ULN in presence of liver metastases
  • 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 (reference appendix "Technical data sheet human albumin")
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419328

Fondazione San Raffaele del Monte Tabor
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Study Director: Antonio Lambiase, MD MolMed S.p.A.