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Isolated Thoracic Perfusion (ITP-F) for MPM

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.

Tracking Information
First Received DateMay 26, 2015
Last Changed DateJune 9, 2015
Start DateSeptember 2009
Actual Primary Completion DateJanuary 2015
Primary Outcome Measures

Survival [Time Frame: one year survival]

Secondary Outcome Measures

Toxicity [Time Frame: 4 weeks after therapy]

Descriptive Information
PhasePhase 2
Study TypeObservational
Condition
  • Mesothelioma
Intervention
  • Drug: Chemotherapy
Study Arms / Comparison Groups0 / 1
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment23
GenderAll
Ages18 Years - 80 Years
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Drug abuse, distant metastases, no bone marrow function

Administrative Information
NCTIDNCT02467426
Responsible Party,
SponsorMedias Klinikum for Surgical Oncology
Verification DateJune 2015
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