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

NCT ID: NCT00484276

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

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.

Conditions

Malignant Pleural Mesothelioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NGR-hTNF

NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly

Group Type: EXPERIMENTAL

NGR-hTNF

Intervention Type: DRUG

iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Interventions

NGR-hTNF

iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGC Biologics S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Lambiase, MD

Role: STUDY_DIRECTOR

AGC Biologics S.p.A.

Locations

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Fondazione San Raffaele del Monte Tabor

Milan, , Italy

Istituto Europeo Oncologico

Milan, , Italy

Istituto Nazionale dei Tumori

Milan, , Italy

Countries

Italy

References

Gregorc V, Zucali PA, Santoro A, Ceresoli GL, Citterio G, De Pas TM, Zilembo N, De Vincenzo F, Simonelli M, Rossoni G, Spreafico A, Grazia Vigano M, Fontana F, De Braud FG, Bajetta E, Caligaris-Cappio F, Bruzzi P, Lambiase A, Bordignon C. Phase II study of asparagine-glycine-arginine-human tumor necrosis factor alpha, a selective vascular targeting agent, in previously treated patients with malignant pleural mesothelioma. J Clin Oncol. 2010 May 20;28(15):2604-11. doi: 10.1200/JCO.2009.27.3649. Epub 2010 Apr 20.

Reference Type: RESULT

PMID: 20406925 (View on PubMed)

Other Identifiers

2006-005993-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NGR010

Identifier Type: -

Identifier Source: org_study_id