Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
- Conditions
- Malignant Pleural Mesothelioma
- Interventions
- Combination Product: intracavitary cisplatin-fibrin
- Registration Number
- NCT01644994
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intracavitary cisplatin-fibrin intracavitary cisplatin-fibrin single dose local intracavitary cisplatin-fibrin application after pleurectomy/decortication
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (Safety) during 6 weeks after surgery with local cisplatin-fibrin application (Serious) Adverse Events \& safety blood parameters (hematology and clinical chemistry)
Cisplatin concentration in the superficial chest wall tissue 90 min after application local cisplatin concentration in the superficial chest wall biopsy measured by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection
- Secondary Outcome Measures
Name Time Method TUNEL assay before and 90 min after cisplatin-fibrin application markers for apoptosis in superficial chest wall tissue
overall survival up to 5 years (phase I), up to 2 years (phase II) time between date of treatment and time point of death or last follow-up, method of Kaplan and Meier
FFR (= Freedom From Recurrence) 4, 16 weeks, then every 4 months up to 5 (phase I) / 2 years (phase II) time to tumor progression by CT or PET-CT/MRI, method of Kaplan and Meier
in-treatment-field FFR (= Freedom From Recurrence) up to 2 years (phase II) 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)
Quality of Life SF-36 (= Short Form-36) phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y change from baseline in SF-36 quality of life questionnaire
Quality of Life EORTC QLQ-C15/LC13 (QLQ = Quality of Life Questionnaire, C = Cancer, LC = Lung Cancer) phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y change from baseline in EORTC Lung Cancer Questionnaire QLQ-C15/LC13
pharmacokinetics cisplatin concentration in blood serum baseline, and 0, 2, 6, 10, 24, 48, 120 h postoperative cisplatin concentration in blood serum by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection
pharmacokinetics cisplatin concentration in urine baseline, collection of first 48h, day 14 postoperative pharmacokinetics, cisplatin concentration in urine by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection
PAI-1 and p21 (PAI-1 = Plasminogen Activator Inhibitor Typ 1, p21 = CDK-Inhibitor 1 = Cyclin Dependent Kinase Inhibitor 1)) before and 90 min after cisplatin-fibrin application markers for senescence in superficial chest wall tissue
Trial Locations
- Locations (1)
University Hospital Zurich, Division of Thoracic Surgery
🇨🇭Zurich, ZH, Switzerland