Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00483093
First received: June 5, 2007
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).


Condition Intervention Phase
Solid Tumors
Drug: NGR-hTNF
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks [ Time Frame: To recommend a dose regimen of NGR-hTNF + Cisplatin for future phase II trials ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To document the preliminary antitumor activity of the combination in terms of objective response rate according to RECIST criteria [ Time Frame: every six weeks ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetic profiles of the combination of NGR-hTNF and cisplatin [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • To measure plasma levels of sTNFRs and anti-NGR-hTNF antibodies [ Time Frame: During the study ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2007
Study Completion Date: April 2013
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NGR-hTNF
iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqm
Drug: Cisplatin
iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles

Detailed Description:

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.

Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.

  Eligibility

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

Inclusion Criteria:

  • Patients ≥18 years with advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and suitable for a treatment with cisplatin

    • Life expectancy more than 3 months
    • ECOG Performance status 0-1
    • Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) may represent a risk for the patient
    • 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
    • Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
    • Patients may have had prior therapy providing the following conditions are met:
  • Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days
  • Corticosteroid therapy wash out period of 14 days
  • Surgery: wash-out period of 14 days
  • Patients must give written informed consent to participate in the study

Exclusion Criteria:

  • Previous signs of severe toxicity platinum related
  • Patients must not receive any other investigational agents while on study
  • New York Heart Association class III or IV cardiac disease
  • Unstable angina
  • Patients with myocardial infarction within the last six (6) months
  • Patient with significant peripheral vascular disease
  • 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: NCT00483093

Locations
Italy
Fondazione San Raffaele del Monte Tabor
Milan, Milan,, Italy
Istituto Europeo Oncologico
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Study Director: Antonio Lambaise, MD MolMed S.p.A.
  More Information

Publications:
Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00483093     History of Changes
Other Study ID Numbers: NGR004, 2006-006035-42
Study First Received: June 5, 2007
Last Updated: May 29, 2014
Health Authority: Italy: National Institute of Health

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

Additional relevant MeSH terms:
Neoplasms
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014