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

NCT00484276 | Completed Phase 2

• 2 other identifiers: NGR0102006-005993-39
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 4

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.

Conditions

Malignant Pleural Mesothelioma

Keywords

NGR-hTNF; malignant pleural mesothelioma

Outcome Measures

Primary Outcomes (1)

• Antitumor activity defined as progression free survival (PFS)

  Defined as the time from the date of randomization until disease progression, or death

  during the study

Secondary Outcomes (6)

• Tumor Growth Control Rate (TGCR)

  Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD

• Overall survival (OS)

  from the randomization until to the date of patient death or discontinuation from the study

• Experimental Imaging Study (DCE-MRI)

  During the treatment

• Cmax of NGR-hTNF in patients treated with weekly schedule

  During the treatment

• AUC(tau) of NGR-hTNF in patients treated with weekly schedule

  During the treatment

Study Arms (1)

NGR-hTNF

EXPERIMENTAL

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

Drug: NGR-hTNF

Interventions

NGR-hTNF DRUG

iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

NGR-hTNF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AGC Biologics S.p.A.: lead

Study Sites (4)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Location

Fondazione San Raffaele del Monte Tabor

Milan, Italy

Location

Istituto Europeo Oncologico

Milan, Italy

Location

Istituto Nazionale dei Tumori

Milan, Italy

Location

Related Publications (1)

• 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.

  PMID: 20406925 RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Antonio Lambiase, MD

  AGC Biologics S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

IT (4)