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

This study has been completed.
Sponsor:
Information provided by:
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00419328
First received: January 5, 2007
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: NGR-hTNF
Phase 1

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: NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To verify safety of escalating doses of NGR-hTNF [ Time Frame: during and following the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To document possible modifications on vessels permeability [ Time Frame: before and following the first treatment ] [ Designated as safety issue: No ]
  • To document signs of anticancer activity [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NGR-hTNF
iv q3W escalating dose up 1.6 mcg/sqm

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

  Eligibility

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

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.
  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: NCT00419328

Locations
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
ClinicalTrials.gov Identifier: NCT00419328     History of Changes
Other Study ID Numbers: NGR002, 2004-002194-23
Study First Received: January 5, 2007
Last Updated: January 28, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by MolMed S.p.A.:
solid tumors NGR-hTNF

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014