Isolated Thoracic Perfusion (ITP-F) for MPM

NCT ID: NCT02467426

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Mesothelioma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemotherapy

intraarterial chemotherapy with cisplatin and mitoxantrone

Chemotherapy

Intervention Type: DRUG

intraarterial infusion of cisplatin and mithoxantrone

Interventions

Chemotherapy

intraarterial infusion of cisplatin and mithoxantrone

Intervention Type: DRUG

Other Intervention Names

CDDP; Mitoxantrone

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Drug abuse, distant metastases, no bone marrow function

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medias Klinikum for Surgical Oncology

OTHER

Sponsor Role: lead

Responsible Party

Prof. Andreas Sendler

Senior Consultant, Dept. of Surgical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl R. Aigner, MD

Role: PRINCIPAL_INVESTIGATOR

Medias Klinikum Burghausen

Related Links

http://www.medias-klinikum.de

homepage of the hospital

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id