Mesothelioma Related Clinical Trials:
A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma


    - General Info     - Purpose     - Eligibility     - Contacts & Locations     - Additional Information

Status: Recruiting
Sponsors and Collaborators: European Lung Cancer Working Party
Information provided by: European Lung Cancer Working Party
Government Identifier: NCT00634205

Condition: Malignant Mesothelioma
Intervention: Drug: Valproate plus doxorubicin

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Purpose:


The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .
Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:   A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma

Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Response rate [ Time Frame: Every 3 courses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the day of registration until death or last follow up ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   41
Study Start Date:   July 2006
Estimated Study Completion Date:   June 2010
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin
Drug: Valproate plus doxorubicin
Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks

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Eligibility:

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

Criteria

Inclusion Criteria:

  • Histological diagnosis of malignant mesothelioma
  • Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)
  • At least one evaluable or measurable CT-lesion
  • Availability for participating in the detailed follow-up of the protocol
  • Signed informed consent

Exclusion Criteria:

  • Patients who are candidates for surgery with curative intent
  • Patient who were previously treated with anthracyclin derivatives
  • Performance status < 60 on the Karnofsky scale
  • A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
  • A history of prior HIV infection
  • Polynuclear cells < 2,000/mm³
  • Platelet cells < 100,000/mm³
  • Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
  • Serum bilirubin >1.5 mg/100 ml
  • Transaminases more than twice the normal range
  • Serum creatinine > 1.5 mg/100 ml
  • Recent myocardial infarction (less than 3 months prior to date of diagnosis)
  • Congestive cardiac failure (ejectional fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia
  • Uncontrolled infectious disease
  • Active epilepsy needing a specific treatment
  • Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
  • Pregnancy or refusal to use active contraception
  • A known allergy to valproate acid and/or doxorubicin
  • Serious medical or psychological factors which may prevent adherence to the treatment schedule

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634205

Contacts
Contact: Nathalie Leclercq, RN     0032/2/5390496     nathalie.leclercq@bordet.be    
Contact: Thierry Berghmans, MD     0032/2/5413111    
Locations
Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet     Recruiting
      Brussels, Belgium, 1000
      Contact: Thierry Berghmans, MD     0032/2/5390496        
      Principal Investigator: Thierry Berghmans, MD            
Department of Pneumology CHU Charleroi     Recruiting
      Charleroi, Belgium, 6000
      Contact: Jacques Lecomte, MD            
      Principal Investigator: Jacques Lecomte, MD            
Department of Pneumology Hôpital Saint-Joseph     Recruiting
      Gilly, Belgium, 6060
      Contact: Benoît Colinet, MD            
      Principal Investigator: Benoît Colinet, MD            
Department of Pneumology CHR St joseph - Warquignies     Recruiting
      Boussu, Belgium, 7360
      Contact: Michel Richez, MD            
      Principal Investigator: Michel Richez, MD            
CH Peltzer-La Tourelle     Recruiting
      Verviers, Belgium, 4800
      Contact: Yves Bonduelle, MD            
      Principal Investigator: Yves Bonduelle, MD            
      Sub-Investigator: Ingrid Louviaux, MD            
Hôpital Ambroise Paré     Recruiting
      Mons, Belgium, 7000
      Contact: Patricia Wackenier, MD            
      Principal Investigator: Patricia Wackenier, MD            
      Sub-Investigator: Stéphane Holbrechts, MD            
Department of Pneumology Hôpital Ixelles-Molière     Recruiting
      Brussels, Belgium
      Contact: Saida Bensliman, MD            
      Principal Investigator: Saida Bensliman, MD            
France
Department of Pneumology CHRU Lille     Recruiting
      Lille, France
      Contact: Arnaud Scherpereel, MD, PhD     0033/320/444998        
      Principal Investigator: Arnaud Scherpereel, MD, PhD            

Sponsors and Collaborators
European Lung Cancer Working Party

Investigators
Study Chair:     Thierry Berghmans, MD     European Lung Cancer Working Party    

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Additional Information:

Responsible Party:   European Lung Cancer Working Party ( Dr Thierry Berghmans )
Study ID Numbers:   ELCWP-01062
First Received:   March 5, 2008
Last Updated:   March 5, 2008
ClinicalTrials.gov Identifier:   NCT00634205
Health Authority:   Belgium: Federal Agency for Medicinal Products and Health Products;   France: Afssaps - French Health Products Safety Agency

Keywords provided by European Lung Cancer Working Party:
Mesothelioma  
Valproate  
Doxorubicin  
Chemotherapy  
Phase II  

Study placed in the following topic categories:
Mesothelioma
Valproic Acid
Adenoma
Doxorubicin
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Neurotransmitter Agents
Neoplasms by Histologic Type
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Mesothelial
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antimanic Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on March 12, 2008

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