Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

February 11, 2015 updated by: European Lung Cancer Working Party

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Boussu, Belgium, 7360
        • Department of Pneumology CHR St joseph - Warquignies
      • Brussels, Belgium, 1000
        • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
      • Brussels, Belgium
        • Department of Pneumology Hôpital Ixelles-Molière
      • Charleroi, Belgium, 6000
        • Department of Pneumology CHU Charleroi
      • Gilly, Belgium, 6060
        • Department of Pneumology Hôpital Saint-Joseph
      • Mons, Belgium, 7000
        • Hôpital Ambroise Paré
      • Verviers, Belgium, 4800
        • CH Peltzer-La Tourelle
  • France
      • Lille, France
        • Department of Pneumology CHRU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: Every 3 courses
Every 3 courses

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Survival will be dated from the day of registration until death or last follow up
Survival will be dated from the day of registration until death or last follow up
Toxicity
Time Frame: After each course of chemotherapy and at the end of treatment
After each course of chemotherapy and at the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Lung Cancer Working Party

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELCWP-01062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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