Status:
COMPLETED
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
Lead Sponsor:
European Lung Cancer Working Party
Conditions:
Malignant Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00634205
Start Date
July 1 2006
End Date
June 1 2010
Last Update
February 12 2015
Active Locations (8)
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1
Department of Pneumology CHR St joseph - Warquignies
Boussu, Belgium, 7360
2
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
3
Department of Pneumology Hôpital Ixelles-Molière
Brussels, Belgium
4
Department of Pneumology CHU Charleroi
Charleroi, Belgium, 6000