Isolated Thoracic Perfusion (ITP-F) for MPM

Completed

• Conditions: Mesothelioma
• Interventions: Drug: Chemotherapy

• Registration Number: NCT02467426
• Lead Sponsor: Medias Klinikum for Surgical Oncology

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-09
• Primary Completion: 2015-01
• Study Completion: 2015-05
• Study First Submitted: 2015-05-26
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-09
• Last Update Submitted: 2015-06-09
• Study First Posted: 2015-06-10
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging

Exclusion Criteria

• Drug abuse, distant metastases, no bone marrow function

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	intraarterial chemotherapy with cisplatin and mitoxantrone

Primary Outcome Measures

Name	Time	Method
Survival	one year survival	Kaplan-Maier Plot

Secondary Outcome Measures

Name	Time	Method
Toxicity	4 weeks after therapy	Toxicity was measured by Common Toxicity Criteria Vers. 2.0