Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma
Conditions
Advanced Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
Malignant Pleural Mesothelioma, MPM, Maintenance treatment, NGR-hTNF
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: NGR-hTNF Type: Drug
Name: Placebo Type: Drug
Name: Best Supportive Care Type: Other
Overall Status
Recruiting
Summary
The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma
Detailed Description
First-line treatment of advanced malignant pleural mesothelioma (MPM) is based on six cycles of a pemetrexed-based chemotherapy, with a median progression-free survival (PFS) of approximately 6 months.However, the median time from completion of first-line treatment to initiation of second-line therapy is approximately 3 months. Recent experiences in non-small cell lung cancer patients have shown that a maintenance treatment given immediately after first-line treatment regimens can improve PFS and survival. Considering the toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms registered in a phase II trial in previously treated MPM patients, as well as the disease control observed in about half of the patients and maintained for more than four months and more than nine months in the triweekly and weekly cohorts, respectively, seems justified to compare in a randomized phase II trial the time-related efficacy of NGR-hTNF against placebo in advanced MPM patients who did not progress after six cycles of a standard pemetrexed-based treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age ≥ 18 years

- Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown

- Patients with non-progressive disease after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease

- Good clinical conditions

- Adequate baseline bone marrow, hepatic and renal function

- Measurable or non-measurable disease according to malignant pleural mesothelioma-modified RECIST criteria

- Patients may have had prior therapy providing the following conditions are met:

- Surgery: wash-out period of 14 days

- Radiation therapy: wash-out period of 28 days

- Chemotherapy: wash-out period of 21 days

Exclusion Criteria:

- Patients must not receive any other investigational agents while on study

- Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication

- Uncontrolled hypertension

- QTc interval (congenital or acquired) > 450 ms

- History or evidence upon physical examination of Central Nervous System disease unless adequately treated

- 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.
Locations
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, Germany
Status: Recruiting
Contact: Claus-Peter Schneider, MD
Asklepios Fachkliniken München-Gauting
München-Gauting, Germany
Status: Recruiting
Contact: Joachim von Pawel, MD
Ospedale Santo Spirito
Casale Monferrato, Alessandria, Italy
Status: Recruiting
Contact: Alberto Muzio, MD
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST
Meldola, Forlì-Cesena, Italy
Status: Recruiting
Contact: Marco Angelo Burgio, MD
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Status: Recruiting
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, Italy
Status: Recruiting
Contact: Federica Grosso, MD
IRCCS Azienda Ospedaliera Universitaria San Martino IST Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy
Status: Recruiting
Contact: Francesco Grossi, MD
Asl 3 genovese, Ospedale Villa Scassi
Genova, Italy
Status: Recruiting
Contact: Manlio Mencoboni, MD
IRCCS Ospedale San Raffaele
Milano, Italy
Status: Recruiting
Contact: Luca Gianni, MD
Istituto Oncologico Veneto
Padova, Italy
Status: Recruiting
Contact: Adolfo Favaretto, MD
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Status: Recruiting
Contact: Marcello Tiseo, MD
IRCCS Policlinico S. Matteo
Pavia, Italy
Status: Recruiting
Contact: Camillo Porta, MD
Azienda Unità Sanitaria locale di Ravenna
Ravenna, Italy
Status: Recruiting
Contact: Claudio Dazzi, MD
Ospedale Ca' Foncello
Treviso, Italy
Status: Recruiting
Contact: Giovanni Rosti, MD
Saint Petersburg State Medical University n.a. I. P. Pavlov
Saint-Petersburg, Russian Federation
Status: Recruiting
Contact: Sergey Vladimirovich Orlov, MD
Start Date
March 2011
Completion Date
December 2016
Sponsors
MolMed S.p.A.
Source
MolMed S.p.A.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page