Malignant MesotheliomaPhase 2NCT00634205
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
A Phase 2 study testing Valproate plus doxorubicin in people with Malignant Mesothelioma, run by European Lung Cancer Working Party at 8 sites in 2 countries.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- Valproate plus doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2006to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Belgium7 sites
Department of Pneumology CHR St joseph - Warquignies
Boussu, 7360
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
Department of Pneumology Hôpital Ixelles-Molière
Brussels
Department of Pneumology CHU Charleroi
Charleroi, 6000
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060
Hôpital Ambroise Paré
Mons, 7000
CH Peltzer-La Tourelle
Verviers, 4800
About this study
Official title: 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 .
- Conditions
- Malignant Mesothelioma
- Being tested
- Valproate plus doxorubicin
- Keywords
- Mesothelioma, Valproate, Doxorubicin, Chemotherapy, Phase II
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproate plus doxorubicinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin Receives: Drug: Valproate plus doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: Every 3 courses
Secondary outcomes (2)
Survival
Measured: Survival will be dated from the day of registration until death or last follow up
Toxicity
Measured: After each course of chemotherapy and at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionMar 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Berghmans, MD, Study chair, European Lung Cancer Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634205
- Sponsor's protocol ID
- ELCWP-01062
- Status last verified
- Feb 2015
- First submitted
- 5 Mar 2008
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.
PubMed 20530048
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT00634205
- Acronym / sponsor ID
- ELCWP-01062
- Conditions
- Malignant Mesothelioma
- Keywords
- Mesothelioma, Valproate, Doxorubicin, Chemotherapy, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Valproate plus doxorubicinContinuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproate plus doxorubicinValproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks | Drug | A |
Primary outcome
Response rate
Time frame: Every 3 courses
2 secondary outcomes
Survival
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Derived from this study: PubMed 20530048Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.
- Click here for more information on the protocolLink provided by the sponsor.
- Trials registry of the French National Cancer InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Berghmans, MD study chair
European Lung Cancer Working Party
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproate plus doxorubicin in people with Malignant Mesothelioma, run by European Lung Cancer Working Party at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Every 3 courses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00634205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.