Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT00634205
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2008-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2008-03-05', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Every 3 courses'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Survival will be dated from the day of registration until death or last follow up'}, {'measure': 'Toxicity', 'timeFrame': 'After each course of chemotherapy and at the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesothelioma', 'Valproate', 'Doxorubicin', 'Chemotherapy', 'Phase II'], 'conditions': ['Malignant Mesothelioma']}, 'referencesModule': {'references': [{'pmid': '20530048', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.elcwp.org', 'label': 'Click here for more information on the protocol'}, {'url': 'http://www.e-cancer.fr', 'label': 'Trials registry of the French National Cancer Institute'}]}, 'descriptionModule': {'briefSummary': '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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of malignant mesothelioma\n* Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)\n* At least one evaluable or measurable CT-lesion\n* Availability for participating in the detailed follow-up of the protocol\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients who are candidates for surgery with curative intent\n* Patient who were previously treated with anthracyclin derivatives\n* Performance status \\< 60 on the Karnofsky scale\n* 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)\n* A history of prior HIV infection\n* Polynuclear cells \\< 2,000/mm³\n* Platelet cells \\< 100,000/mm³\n* Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen\n* Serum bilirubin \\>1.5 mg/100 ml\n* Transaminases more than twice the normal range\n* Serum creatinine \\> 1.5 mg/100 ml\n* Recent myocardial infarction (less than 3 months prior to date of diagnosis)\n* Congestive cardiac failure (ejectional fraction of the left ventricle \\< 50%) or uncontrolled cardiac arrhythmia\n* Uncontrolled infectious disease\n* Active epilepsy needing a specific treatment\n* Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine\n* Pregnancy or refusal to use active contraception\n* A known allergy to valproate acid and/or doxorubicin\n* Serious medical or psychological factors which may prevent adherence to the treatment schedule'}, 'identificationModule': {'nctId': 'NCT00634205', 'briefTitle': 'Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'European Lung Cancer Working Party'}, 'officialTitle': 'A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma', 'orgStudyIdInfo': {'id': 'ELCWP-01062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin', 'interventionNames': ['Drug: Valproate plus doxorubicin']}], 'interventions': [{'name': 'Valproate plus doxorubicin', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7360', 'city': 'Boussu', 'country': 'Belgium', 'facility': 'Department of Pneumology CHR St joseph - Warquignies', 'geoPoint': {'lat': 50.43417, 'lon': 3.7944}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Pneumology Hôpital Ixelles-Molière', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Department of Pneumology CHU Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '6060', 'city': 'Gilly', 'country': 'Belgium', 'facility': 'Department of Pneumology Hôpital Saint-Joseph', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '4800', 'city': 'Verviers', 'country': 'Belgium', 'facility': 'CH Peltzer-La Tourelle', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'city': 'Lille', 'country': 'France', 'facility': 'Department of Pneumology CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Thierry Berghmans, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'European Lung Cancer Working Party'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Lung Cancer Working Party', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}