Isolated Thoracic Perfusion (ITP-F) for MPM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02467426|
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : June 10, 2015
|Condition or disease||Intervention/treatment|
Treatment of patients with progressive malignant pleural mesothelioma (MPM) after multimodal therapy is a therapeutic challenge. Survival of the patients is low and the treatment options are sparse. This is an observational study of isolated thoracic perfusion with subsequent hemofiltration as a locoregional therapeutic strategy in this situation.
23 pts. with epithelioid MPM were included in this phase II study after informed consent. All patients had progressive disease after multiple therapies and were recommended BSC of a MDT. Following insertion of a venous and arterial 21 ch. stop flow catheter via a femoral access, the inferior vena cava was blocked beneath the right atrium, the arterial catheter was blocked in the aorta at the diaphragm. The upper arms were blocked by pneumatic cuffs. Chemotherapy was given via the arterial catheter. Chemotherapy consisted of 60mg/m2 cisplatinum and 15mg/m2 mitoxantrone q for 3 weeks until progress. After administration of chemotherapy, thoracic perfusion with blocked stop-flow catheters was maintained for 15 minutes. After de-blocking of the catheters, hemofiltration was performed for 45 min. with 5l filtrate. The endpoint of the study was overall survival.Secondary endpoint was toxicity.
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||Isolated Thoracic Perfusion With Hemofiltration (ITP-F) for Pretreated and Progressive Malignant Pleural Mesothelioma|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||May 2015|
intraarterial chemotherapy with cisplatin and mitoxantrone
intraarterial infusion of cisplatin and mithoxantrone
- Survival [ Time Frame: one year survival ]Kaplan-Maier Plot
- Toxicity [ Time Frame: 4 weeks after therapy ]Toxicity was measured by Common Toxicity Criteria Vers. 2.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467426
|Principal Investigator:||Karl R. Aigner, MD||Medias Klinikum Burghausen|