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Isolated Thoracic Perfusion (ITP-F) for MPM

Isolated Thoracic Perfusion With Hemofiltration (ITP-F) for Pretreated and Progressive Malignant Pleural Mesothelioma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02467426
Enrollment
23
Registered
2015-06-10
Start date
2009-09-30
Completion date
2015-05-31
Last updated
2015-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma

Keywords

Mesothelioma, malignant, Chemotherapy

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.

Interventions

DRUGChemotherapy

intraarterial infusion of cisplatin and mithoxantrone

Sponsors

Medias Klinikum for Surgical Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Drug abuse, distant metastases, no bone marrow function

Design outcomes

Primary

MeasureTime frameDescription
Survivalone year survivalKaplan-Maier Plot

Secondary

MeasureTime frameDescription
Toxicity4 weeks after therapyToxicity was measured by Common Toxicity Criteria Vers. 2.0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026