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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproate plus doxorubicin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Every 3 courses |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival will be dated from the day of registration until death or last follow up | |
| Toxicity | After each course of chemotherapy and at the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Berghmans, MD | European Lung Cancer Working Party | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pneumology CHR St joseph - Warquignies | Boussu | 7360 | Belgium | |||
| Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20530048 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for more information on the protocol | View source |
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| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Brussels |
| 1000 |
| Belgium |
| Department of Pneumology Hôpital Ixelles-Molière | Brussels | Belgium |
| Department of Pneumology CHU Charleroi | Charleroi | 6000 | Belgium |
| Department of Pneumology Hôpital Saint-Joseph | Gilly | 6060 | Belgium |
| Hôpital Ambroise Paré | Mons | 7000 | Belgium |
| CH Peltzer-La Tourelle | Verviers | 4800 | Belgium |
| Department of Pneumology CHRU Lille | Lille | France |
| Trials registry of the French National Cancer Institute | View source |
| D018301 |
| Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |