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

Sponsor:	MolMed S.p.A.
Information provided by (Responsible Party):	MolMed S.p.A.
ClinicalTrials.gov Identifier:	NCT00484276

Purpose

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.

Condition	Intervention	Phase
Malignant Pleural Mesothelioma	Drug: NGR-hTNF	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma

U.S. FDA Resources

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

Primary Outcome Measures:

• Antitumor activity defined as progression free survival (PFS) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Tumor Growth Control Rate (TGCR) according to RECIST criteria • Overall survival (OS) [ Time Frame: during the study ] [ Designated as safety issue: No ]
• Experimental Imaging Study (DCE-MRI) [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
• Pharmacokinetics in patients treated with weekly schedule [ Time Frame: During the treatment ] [ Designated as safety issue: No ]
•Safety [ Time Frame: During the treatment and during the follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	57
Study Start Date:	May 2007
Estimated Study Completion Date:	March 2012
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: NGR-hTNF iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484276

Locations

Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Istituto Europeo Oncologico
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Fondazione San Raffaele del Monte Tabor
Milan, Italy

Sponsors and Collaborators

MolMed S.p.A.

Investigators

Study Director:

Antonio Lambiase, MD

MolMed S.p.A.

More Information

Publications:

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 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. Epub 2010 Apr 20.

Responsible Party:	MolMed S.p.A.
ClinicalTrials.gov Identifier:	NCT00484276 History of Changes
Other Study ID Numbers:	NGR010, EUDRACT Number: 2006-005993-39
Study First Received:	June 7, 2007
Last Updated:	December 30, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by MolMed S.p.A.:

NGR-hTNF
malignant pleural mesothelioma

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on February 12, 2012