Clinical trial NCT00419328: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors
Official title: NGR002: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors: Definition of an Optimal Biological Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: solid tumors NGR-hTNF
Lead sponsor: AGC Biologics S.p.A.
Sponsor class: INDUSTRY
First posted: 2007-01-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: To verify safety of escalating doses of NGR-hTNF
timeFrame: during and following the treatment
Secondary outcomes:
measure: To document possible modifications on vessels permeability
timeFrame: before and following the first treatment
measure: To document signs of anticancer activity
timeFrame: every 6 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione San Raffaele del Monte Tabor
Study officials:
affiliation: AGC Biologics S.p.A.
name: Antonio Lambiase, MD
role: STUDY_DIRECTOR
References:
citation: Gregorc V, Citterio G, Vitali G, Spreafico A, Scifo P, Borri A, Donadoni G, Rossoni G, Corti A, Caligaris-Cappio F, Del Maschio A, Esposito A, De Cobelli F, Dell'Acqua F, Troysi A, Bruzzi P, Lambiase A, Bordignon C. Defining the optimal biological dose of NGR-hTNF, a selective vascular targeting agent, in advanced solid tumours. Eur J Cancer. 2010 Jan;46(1):198-206. doi: 10.1016/j.ejca.2009.10.005.