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

Malignant Pleural Mesothelioma Clinical Trial

— NGR010  

Official title:

NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484276
• Other study ID #: NGR010
• Secondary ID: 2006-005993-39
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: March 2013

Study information

• Verified date: January 2019
• Source: MolMed S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma

Intervention

Drug:
• NGR-hTNF
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Locations

Country	Name	City	State
Italy	Fondazione San Raffaele del Monte Tabor	Milan
Italy	Istituto Europeo Oncologico	Milan
Italy	Istituto Nazionale dei Tumori	Milan
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
MolMed S.p.A.

Country where clinical trial is conducted

Italy, 

References & 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 Viganò M, Fontana F, De Braud FG, Bajetta E, Caligaris-Cappio F, Bruzzi P, Lambiase A, Bordignon C. Phase II study o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tumor Growth Control Rate (TGCR)	Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma	Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD
Secondary	Overall survival (OS)	Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive	from the randomization until to the date of patient death or discontinuation from the study
Secondary	Experimental Imaging Study (DCE-MRI)	To document possible modifications on vessels permeability by imaging techniques	During the treatment
Secondary	Cmax of NGR-hTNF in patients treated with weekly schedule	to evaluate Cmax of NGR-hTNF administered weekly	During the treatment
Secondary	AUC(tau) of NGR-hTNF in patients treated with weekly schedule	to evaluate AUC(tau) of NGR-hTNF administered weekly	During the treatment
Secondary	Safety according to NCI-CTCAE criteria (version 3)	To evaluate safety profile related to NGR-hTNF	During the treatment and during the follow-up