There are currently only three phase III (or phase II/III) clinical trails for mesothelioma listed in the National Cancer Institute trial database. Most of the location are in Europe with the one exception being a Pennsylvania trial. The trials are listed below for your convenience.
Search Criteria:
Cancer Type/Condition: Mesothelioma
Trial Type: Treatment
Trial Status: Active
Trial Phase: Phase IV, Phase III
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Trial Listings
1. Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma
Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Active 18 and over Pharmaceutical / Industry 2005_010
MK0683-014, NCT00128102
Trial Description
Summary
This is a Phase III a study which incorporates an initial Phase II component to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural Mesothelioma.
Revised (20-Dec-2007)
Eligibility Criteria
Inclusion Criteria:
Patient must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma.
Patient must have failed prior chemotherapy that included pemetrexed with either cisplatin or carboplatin.
Patient must have adequate bone marrow, liver and kidney function.
Patient must be capable of self-care and out of bed for more than 50% of waking hours.
Patient must have ability to swallow pills.
Exclusion Criteria:
Patient has been treated with other investigational agent that has similar properties
Patient has an active infection within 2 weeks of the start of study drug, or had treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug.
Patient is pregnant or breast feeding
Trial Contact Information
Trial Lead Organizations/Sponsors
Merck and Company, Incorporated
Medical Monitor Study Director
Toll Free Number Ph: 1-888-577-8839
Trial Sites
U.S.A.
Pennsylvania
Pittsburgh
Call for Information
Belgium
Bruxelles
Merck Sharp & Dohme Limited
Nathalie Schrameijer Ph: 32-2-373-4310
Brazil
Sao Paulo
Sao Paulo
Merck Sharp & Dohme Farmaceutica Ltda.
Jose Octavio P. Costa Filo Ph: 55-11-5189-7942
Germany
Haar
Merck Sharp & Dohme GmbH - Germany
Thomas Lang Ph: 49-89-4561-1536
Italy
Roma
Merck Sharp and Dohme - Rome
Gianfranco Botta Ph: 39 06 36 191187
Netherlands
Haarlem
Merck Sharp & Dohme B.V.
Gerard Van Leijenhorst Ph: 31 23 515 3306
New Zealand
Auckland
Merck Sharp and Dohme New Zealand LTD
David Woolner Ph: 64-9523-6075
Spain
Madrid
Merck Sharp and Dohme de Espana, SA
Jorge Gonzalez-Esteban Ph: 34 91 3210726
Sweden
Sollentuna
Merck Sharp & Dohme (Sweden) AB
Roger Juhlin Ph: 46-8-626-1 458
United Kingdom
Hoddesdon
Merck Sharp & Dohme Limited - United Kingdom
Paul Robinson Ph: 44 1992 452341
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2. Mesothelioma Avastin Plus Pemetrexed-Cisplatin Study
Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Active 18 to 75 Other IFCT-GFPC-ELCWP-0701
NCT00651456
Trial Description
Summary
Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
Further Study Information
A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity.
As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.
Eligibility Criteria
Inclusion Criteria:
Malignant, histologically proved, non resectable pleural Mesothelioma
In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis.
ECOG Performance status 0-2
Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria)
At least 18 years of age, less than 76 years of age
Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days
Exclusion Criteria:
Prior chemotherapy
Brain metastasis
History of cerebral vascular accident (CVA) or transient ischemic attack
Trial Contact Information
Trial Lead Organizations/Sponsors
French Thoracic Oncology Intergroup Center
CHU de Caen
Groupe Francais de Pneumo-Cancerologie
European Lung Cancer Working Party
Gilles Robinet, Dr Study Director
Arnaud Scherpereel, Dr Study Director
Gérard Zalcman, Pr Ph: 33-2-31-06-44-76
Franck Morin
Email: franck.morin@ifct.fr
Trial Sites
Belgium
BRUXELLES
Institut Jules Bordet
Thierry Berghmans, Dr Ph: +32 25 41 31 11
France
Belfort
Centre Hospitalier - Pneumologie
Jean-Luc Breton, Dr Ph: +33 3 84 98 51 18
Besancon
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Pascale Jacoulet, Dr
CAEN
CHU de Caen
Gerard Zalcman, Pr
Clamart
Hopital d'Instruction des Armees Percy
Jacques Margery, Dr
Grenoble
CHU de Grenoble - Hopital de la Tronche
Denis Moro-Sibilot, Pr
Denis Moro-Sibilot, Pr Principal Investigator
Le Havre
Centre Hospitalier - Pneumologie
Philippe Hubscher, Dr
Le Mans
Centre Hospitalier - Pneumologie
Francois-Xavier Lebas, Dr
Olivier Molinier, Dr
Lille
CHU (Hôpital Calmette) - Pneumologie
Arnaud Scherpereel, Dr
LYON
HCL - Croix-Rousse
Maurice Pérol, Dr
Marseille
Hopital Sainte Marguerite
Philippe ASTOUL, Pr
PARIS
Hopital Tenon
Bernard MILLERON, Dr
Pierre Bénite
Centre Hospitalier Lyon Sud
Pierre-Jean Souquet, Dr
Strasbourg
Hopital Lyautey
Elisabeth Quoix, Pr
Elisabeth Quoix, Pr Principal Investigator
Toulouse
CHU de Toulouse, Hotel Dieu
Julien Mazieres, Pr
VILLEJUIF
Institut Gustave Roussy
Pierre Ruffié, Dr Ph: +33 1 42 11 42 11
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3. Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
First Published: 1/12/2009
Alternate Title
Phase III Randomized Study of Video-Assisted Thoracoscopic Cytoreductive Pleurectomy Versus Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma
Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 18 and over Other PAPWORTH-MESOVAT
MESOVAT, PAPWORTH-P00804, EU-20901, ISRCTN34321019, NCT00821860
Trial Description
Purpose:
Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.
This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
Eligibility:
Eligibility criteria include the following:
At least 18 years old
Has a pleural effusion
No previous pleurodesis
For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention:
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Patients in group one will undergo video-assisted surgery at biopsy or at a later time.
Patients in group two will undergo talc pleurodesis at biopsy or at a later time.
Quality of life will be assessed at the beginning of the study and at 1, 3, 6, and 12 months.
Trial Contact Information
Trial Lead Organizations
Papworth Hospital
Robert Winter, MD, Principal investigator Ph: 44-1480-364-821
Trial Sites
United Kingdom
England
Basildon
Basildon University Hospital
Contact Person Ph: 44-1268-533-911
Cambridge
Papworth Hospital
Contact Person Ph: 44-1480-364-821
Leicester
Glenfield Hospital
Contact Person Ph: 44-116-287-1471
London
Guy's Hospital
Contact Person Ph: 44-20-7188-7188
Sheffield
Royal Hallamshire Hospital
Contact Person Ph: 44-114-271-1900