Isolated Thoracic Perfusion (ITP-F) for MPM

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467426
• Other study ID #: 0001
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2015
• Last updated: June 9, 2015
• Start date: September 2009
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Medias Klinikum for Surgical Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

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.

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 / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Drug abuse, distant metastases, no bone marrow function

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mesothelioma

Intervention

Drug:
• Chemotherapy
intraarterial infusion of cisplatin and mithoxantrone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medias Klinikum for Surgical Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Kaplan-Maier Plot	one year survival	No
Secondary	Toxicity	Toxicity was measured by Common Toxicity Criteria Vers. 2.0	4 weeks after therapy	Yes

External Links

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