Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02467426
Study type Observational
Source Medias Klinikum for Surgical Oncology
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date May 2015

See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT06057935 - A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma Phase 2
Terminated NCT02838745 - Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT01912547 - Thromboelastography During Surgery for Malignant Pleural Mesothelioma Phase 0
Completed NCT01521325 - A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers Phase 1
Recruiting NCT00996385 - Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma Phase 2
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed NCT00407459 - Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma Phase 2
Completed NCT00787410 - An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma Phase 2
Terminated NCT01907100 - Nintedanib (BIBF 1120) in Mesothelioma Phase 2/Phase 3
Completed NCT04056026 - A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma Early Phase 1
Completed NCT02903914 - Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Terminated NCT03319537 - Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1
Recruiting NCT03683680 - Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers N/A