This is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in malignant pleural mesothelioma.
|First Received Date||May 26, 2015|
|Last Changed Date||June 9, 2015|
|Start Date||September 2009|
|Actual Primary Completion Date||January 2015|
|Primary Outcome Measures||
Survival [Time Frame: one year survival]
|Secondary Outcome Measures||
Toxicity [Time Frame: 4 weeks after therapy]
|Study Arms / Comparison Groups||0 / 1|
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.
|Ages||18 Years - 80 Years|
|Accepts Healthy Volunteers||No|
- History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging
- Drug abuse, distant metastases, no bone marrow function
|Responsible Party||Principal Investigator|
|Sponsor||Medias Klinikum for Surgical Oncology|
|Verification Date||June 2015|