Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01644994
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open Label, single dose local intracavitary application of Cisplatin bound to Fibrin after surgery (removal of Tumor)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pharmacokinetics cisplatin concentration in pleural effusion', 'timeFrame': 'Pleural effusion collection: 0-48 h postoperative', 'description': 'cisplatin concentration in pleural effusion by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety)', 'timeFrame': 'during 6 weeks after surgery with local cisplatin-fibrin application', 'description': '(Serious) Adverse Events \\& safety blood parameters (hematology and clinical chemistry)'}, {'measure': 'Cisplatin concentration in the superficial chest wall tissue', 'timeFrame': '90 min after application', 'description': 'local cisplatin concentration in the superficial chest wall biopsy measured by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'up to 5 years (phase I), up to 2 years (phase II)', 'description': 'time between date of treatment and time point of death or last follow-up, method of Kaplan and Meier'}, {'measure': 'FFR (= Freedom From Recurrence)', 'timeFrame': '4, 16 weeks, then every 4 months up to 5 (phase I) / 2 years (phase II)', 'description': 'time to tumor progression by CT or PET-CT/MRI, method of Kaplan and Meier'}, {'measure': 'in-treatment-field FFR (= Freedom From Recurrence)', 'timeFrame': 'up to 2 years (phase II)', 'description': 'time to tumor progression by CT or PET-CT/MRI in the chest cavity where the investigational medicinal product was applied, method of Kaplan and Meier (PET-CT = positron emission computed tomography)'}, {'measure': 'Quality of Life SF-36 (= Short Form-36)', 'timeFrame': 'phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y', 'description': 'change from baseline in SF-36 quality of life questionnaire'}, {'measure': 'Quality of Life EORTC QLQ-C15/LC13 (QLQ = Quality of Life Questionnaire, C = Cancer, LC = Lung Cancer)', 'timeFrame': 'phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y', 'description': 'change from baseline in EORTC Lung Cancer Questionnaire QLQ-C15/LC13'}, {'measure': 'pharmacokinetics cisplatin concentration in blood serum', 'timeFrame': 'baseline, and 0, 2, 6, 10, 24, 48, 120 h postoperative', 'description': 'cisplatin concentration in blood serum by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection'}, {'measure': 'pharmacokinetics cisplatin concentration in urine', 'timeFrame': 'baseline, collection of first 48h, day 14 postoperative', 'description': 'pharmacokinetics, cisplatin concentration in urine by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection'}, {'measure': 'TUNEL assay', 'timeFrame': 'before and 90 min after cisplatin-fibrin application', 'description': 'markers for apoptosis in superficial chest wall tissue'}, {'measure': 'PAI-1 and p21 (PAI-1 = Plasminogen Activator Inhibitor Typ 1, p21 = CDK-Inhibitor 1 = Cyclin Dependent Kinase Inhibitor 1))', 'timeFrame': 'before and 90 min after cisplatin-fibrin application', 'description': 'markers for senescence in superficial chest wall tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Pleural Mesothelioma']}, 'descriptionModule': {'briefSummary': 'The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and efficacy in phase II with the maximum tolerated dose in phase I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient is able to understand and willing to sign a written informed consent document.\n* Male or female, age \\>=18 years\n* ECOG performance status =\\<2 (ECOG = Eastern Cooperative Oncology Group)\n* Resectable MPM (Malignant Pleural Mesothelioma) histologically confirmed (phase I: stage cT1-cT4 cN0-cN3 cM0-cM1 / phase II: stage cT1-cT3 cN0-cN1 cM0) (TNM Tumor staging abbreviations: c = clinical; T = Tumor, N = lymph Nodes, M = Metastases; numbers = quantity)\n* Only Phase II: Mediastinal staging (cytological or histological)\n* Only Phase II: Induction chemotherapy (3 or more cycles cisplatin or carboplatin (also in combination with other therapeutic agents)\n* Patient qualifying for (extended) pleurectomy/decortication ((e)P/D) or extrapleural pneumonectomy (EPP) for resection of MPM, which has to be assessed during a multidisciplinary tumor board including a thoracic surgeon\n* Patient must have appropriate organ and bone marrow function as defined: hematologic function: hemoglobin ≥100 g/L, WBC (white blood cell count) ≥3.5 G/L, neutrophils ≥1.5 G/L, thrombocytes ≥100 G/L; liver function: total bilirubin and LDH (lactate dehydrogenase) ≤1.5 x ULN (upper limit of normal); AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma glutamyltransferase), and AP (alkaline phosphatase) ≤2.5 x ULN; renal function: creatinine ≤130 μmol/L or, if greater, creatinine clearance ≥60 ml/min/1.73m2.\n* Patient must have an appropriate blood coagulation for P/D or EPP (Quick-test \\> 50%, INR (international normalized ratio) \\<=1.2)\n* The patient agrees to use an efficient contraceptive treatment up to 3 months after cisplatin application if required (pre-menopausal women and men in a sexually mature age).\n* Heart and lung function allowing P/D under general anesthesia\n\nExclusion criteria:\n\n* Known or suspected unwillingness of the patient to follow the rules of the protocol\n* Patient who has not recovered from side effects from prior chemotherapy or radiotherapy.\n* Any known hypersensitivity against cisplatin or other platinum containing substances or any other components used for the preparation of the drugs.\n* Patient must not receive any other investigational agents 4 weeks before treatment and until the end of the observation period (2 months after treatment).\n* Patient with prior ipsilateral pleurectomy\n* Only Phase II: Multimodality Prognostic Score (MMPS) \\> 2:\n\n 4 items with a maximum possible score of 4 if the patient presented all four conditions and 0 if none were present: Tumor volume before induction chemotherapy \\> 500 ml, non-epithelioid histotype in the diagnostic biopsy before induction chemotherapy, CRP (C reactive protein) value \\> 30 mg/l before induction chemotherapy, and progressive disease after induction chemotherapy according to RECIST criteria\n* Patient with uncontrolled intercurrent illnesses that would limit the operative procedure of P/D / EPP or compliance with study requirements\n* Tinnitus impairment of more than severity grade I (slight) evaluated by the tinnitus questionnaire MiniTF12\\_CH (Mini Tinnitus Fragebogen 12, CH = Confoederatio Helvetica (Swiss version)), and/or restricted power of hearing until 4 kHz (kilohertz) confirmed by audiometry, unless age-related presbyacusis in a normal range confirmed by an audiologist.\n* Known alcohol and/or drug abuse at the time of screening\n* Pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT01644994', 'briefTitle': 'Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Phase I Dose-Escalation /Phase II Monocentric Open Trial for Evaluation of Safety and Efficacy of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication or Extrapleural Pneumonectomy for the Treatment of Patients With Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'INFLuenCe - Meso'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intracavitary cisplatin-fibrin', 'description': 'single dose local intracavitary cisplatin-fibrin application after pleurectomy/decortication', 'interventionNames': ['Combination Product: intracavitary cisplatin-fibrin']}], 'interventions': [{'name': 'intracavitary cisplatin-fibrin', 'type': 'COMBINATION_PRODUCT', 'description': 'single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication', 'armGroupLabels': ['intracavitary cisplatin-fibrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Thoracic Surgery', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Isabelle Opitz, Professor MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Thoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}, {'name': 'Swiss Accident Insurance Fund SUVA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}