Ongoing Mesothelioma Clinical Trials

Last Updated September 27, 2010

What you should know about clinical trials.

Additional Information About Clinical Trials can be found:

Open Clinical Trials - In this section, the following ongoing clinical trials are discussed:

DIAGNOSTIC TRIALS

Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer

The purpose of this study is to use cone-beam CT scans to more accurately position the tumor during radiation. The ability to eliminate the tumor with radiation depends in part on the accuracy of delivering the radiation to the lung. With cone-beam CT scans taken before and during your treatment, we will be able to determine the location of the tumor with 3D images, measure how much the tumor moves as you breathe, and then position you so that the tumor will get the best delivery of radiation.

Trial site: NY
Last updated: April 5, 2010

RADIATION

Short Neoadjuvant Hemithoracic IMRT for MPM

The study will look at whether giving a short intense course of chest radiation just prior to surgery will sterilize these tumor cells and thus, avoid or reduce contamination of the areas outside the chest cavity. The investigators hypothesize that short neoadjuvant (pre-operative) hemithoracic RT, followed by immediate planned extrapleural pneumonectomy (EPP) (+/- adjuvant chemotherapy) will reduce the risk of intra-operative seeding and reduce the incidence of distant metastatic disease

Trial site: Canada
Last updated: April 5, 2010

Tomotherapy Treatment for Mesothelioma

This trial explores the use of new radiation technology (tomotherapy), to treat mesothelioma more aggressively than has been possible before. Tomotherapy's ability to treat unusual shaped tumors, particularly when they are wrapped around sensitive normal tissues (the lung), enable higher doses of radiation to be used and this may improve its effectiveness.

Trial site: Canada
Last updated: March 18, 2010

VIDEO-ASSISTED SURGERY vs. TALC PLEURODESIS

Phase III Randomized Study of Video-Assisted Thoracoscopic Cytoreductive Pleurectomy Versus Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma

This trial compares the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs. talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant. 

Trial site: England
Last updated: June 7, 2009

SURGERY COMBINED WITH CHEMOTHERAPY

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.

Trial site: MA
Last updated: April 5, 2010

Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis  

This trial aims to determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin.  

Trial site: China
Last updated: March 18, 2010

Phase II Randomized Study of Neoadjuvant Therapy With Pemetrexed Disodium and Cisplatin Followed By Extrapleural Pneumonectomy With or Without Postoperative Hemithoracic Radiotherapy in Patients With Malignant Pleural Mesothelioma   

This trial evaluates the short-term outcomes and feasibility of neoadjuvant therapy with pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy in patients with malignant pleural mesothelioma.

Trial site: Germany, Switzerland
Last updated: July 19, 2009

TRIMODAL THERAPY

Trimodal Lung-Sparing Treatment of Pleural Mesothelioma    

We will investigate whether a prospective trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed treatment will include exploratory thoracoscopy, placement of Mediport catheters into the pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and intrapleural instillation of radioactive P32 to radiate the pleural surfaces. We hope to alter the currently accepted paradigm that major lung surgery is an inescapable component of such treatment, and advance the concept that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional drug treatment of the pleural surfaces may offer the best hope for prolongation of survival with intact lung function.    

Trial site: NY
Last updated: April 12, 2010

Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma

In an effort to achieve a better chance of complete removal of the cancer and long term survival, the investigators are interested in using this drug combination of Pemetrexed + Cisplatin before surgery and offer radiation therapy after surgery. 

Trial site: Canada
Last updated: April 5, 2010

CHEMOTHERAPY & OTHER DRUG AGENTS

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

IMC-A12 is a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration

It is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide.

Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy.

Trial site: Bethesda, MD
Last updated: September 27, 2010

Phase II Randomized Study of Pemetrexed Disodium Maintenance Therapy Versus Observation in Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy       

To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.         

Trial site: MN
Last updated: May 14, 2010

Phase I/II Randomized Study of Pemetrexed Disodium and Cisplatin With Versus Without Cediranib Maleate in Patients With Malignant Pleural Mesothelioma        

To establish the maximum tolerated dose and the recommended phase II dose of cediranib maleate in combination with pemetrexed disodium and cisplatin in patients with malignant pleural mesothelioma. (Phase I) and to compare the progression-free survival of patients treated with pemetrexed disodium and cisplatin with vs without cediranib maleate. (Phase II).

Trial site: TX
Last updated: May 12, 2010

Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma   

This is a study 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.

Trial site: U.S.A (multiple sites) and International (multiple sites)
Last updated: May 11, 2010

Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma

This study is being conducted to evaluate the overall safety and effectiveness of an investigational drug, GC1008, in patients with mesothelioma.     

Trial site: PA, IL
Last updated: May 4, 2010

Phase II Study of Anti-HGF Monoclonal Antibody AMG 102 in Combination With Pemetrexed Disodium and Cisplatin in Patients With Malignant Pleural Mesothelioma                          

To evaluate the progression-free survival of patients with malignant pleural mesothelioma (MPM) treated with anti-HGF monoclonal antibody AMG 102 in combination with pemetrexed disodium and cisplatin.

Trial site: NJ
Last updated: April 14, 2010

Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma                          

This chemotherapy study will consist of four treatments with Velcade and two treatments with Eloxatin. Patients will undergo standard of care blood work and Quality of Life (QOL) questionnaires at each visit and will be have repeat CT scans performed to assess tumor response every 2 cycles. Following discontinuation of treatment due to disease progression or completion of therapy, patient's will be followed for survival, QOL assessments, and tumor assessments every 3 months (or as clinically indicated) for the first year and every 3 months thereafter for a maximum of 5 years.

Trial site: NY
Last updated: April 12, 2010

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.

Trial site: Italy
Last updated: April 5, 2010

Study of CBP501 + Pemetrexed + Cisplatin in Patients With Solid Tumors (Phase I) and Patients With Malignant Pleural Mesothelioma (Phase II)

The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients.

Trial site: U.S.A (multiple sites)
Last updated: April 5, 2010

A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma    

The purpose of this study is to evaluate the antitumor activity of a combination of Imatinib mesylate and Gemcitabine in patients with unresectable malignant mesothelioma expressing either PDGFR-beta or C-kit.

Trial site: Italy
Last updated: April 5, 2010

A Study of Cetuximab Combined With Cisplatin or Carboplatin/Pemetrexed as First Line Treatment in Patients With Malignant Pleural Mesothelioma.      

In this trial, patients will be treated with standard chemotherapy, combined with Cetuximab weekly. After a maximum of 6 cycles of chemotherapy, administration of Cetuximab will be continued until disease progression.     

Trial site: Belgium
Last updated:  April 5, 2010

Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity     

The purpose of this study is to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus works by blocking a protein that helps the cancer grow. The goal of this clinical research study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma. The safety of this drug will also be studied.

Trial site: NY
Last updated: April 5, 2010

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma   

This trial aims to estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab

Trial site: TX
Last updated: March 18, 2010

An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

Milataxel is a new taxane that may have several advantages over the currently available taxanes. The current study is designed to determine the response rate of oral Milataxel in patients with malignant Mesothelioma. The study specifically targets patients who have recurring or progressive disease following previous chemotherapy. 

Trial site: IL, NY
Last updated: March 18, 2010

Phase II Study of Pemetrexed Disodium, Cisplatin, and Vitamin B12 in Patients With Unresectable Pleural Mesothelioma        

This trial aims to define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin, and vitamin B12 in patients with unresectable pleural mesothelioma.      

Trial site: France
Last updated: July 5, 2009

Phase II Study of Bortezomib in Patients With Malignant Pleural Mesothelioma     

This trial aims to assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.

Trial site: International (multiple sites)
Last updated: August 3, 2007

Phase II Study of AZD2171 in Patients With Malignant Pleural, Peritoneal, or Tunica Vaginalis Mesothelioma That is Not Amenable to Curative Surgery    

This trial aims to determine the objective response rate in patients with malignant pleural, peritoneal, or tunica vaginalis mesothelioma who are treated with AZD2171 because their condition is not amenable to curative surgery. 

Trial site: U.S.A (multiple sites), Canada
Last updated: June 3, 2007

PAIN MANAGEMENT & PALLIATIVE CARE

Phase III Randomized Study of an Electronic Tool for Monitoring Symptoms and Syndromes Associated With Advanced Cancer (E-MOSAIC) in Patients With Advanced Incurable Cancer Receiving Palliative Anticancer Treatment    

Determine the effect of an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS) on global quality of life (G-QOL) of patients with advanced incurable cancer receiving palliative anticancer treatment.

Trial site: Switzerland
Last updated: July 19, 2009

Phase III Randomized Study of Fentanyl Sublingual Spray for Breakthrough Cancer Pain in Patients Who are Opioid Tolerant    

Determine the efficacy and safety of fentanyl sublingual (SL) spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain.  

Trial site: TX
Last updated: October 10, 2008