New Mesothelioma Trial Involves a Placebo

The following clinical trials are very unusual in that it uses a placebo versus a new treatment.  Placebos are rarely used in cancer trials or other trials involving life threatening diseases.  These trials are listed in PDQ, the cancer information database of the National Cancer Institute (NCI).  All but one of the trial locations is in Europe with the lone American site being in Pittsburgh, Pennsylvania.

1.  Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

Basic Trial Information

Phase III, Phase II Treatment trial.
Trail is active and accepting patients.
Age:  18 and over

   
Pharmaceutical / Industry trial

   
ID numbers:  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
 
Germany
 
  Haar  

 
  Merck Sharp & Dohme GmbH - Germany
 
  Thomas Lang Ph: 49-89-4561-1536
 
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
 

Link to the current ClinicalTrials.gov record. 1
NLM Identifer NCT00128102
Information obtained from ClinicalTrials.gov on March 21, 2008

2.  Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

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
 

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00128102
Information obtained from ClinicalTrials.gov on August 07, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.
Note: Information about this trial is from the ClinicalTrials.gov database.