Trials / Completed
CompletedNCT01644994
Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | intracavitary cisplatin-fibrin | single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2019-12-01
- Completion
- 2021-08-01
- First posted
- 2012-07-19
- Last updated
- 2021-09-29
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01644994. Inclusion in this directory is not an endorsement.