Isolated Thoracic Perfusion (ITP-F) for MPM

Brief Title

Isolated Thoracic Perfusion (ITP-F) for MPM

Official Title

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

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 Type

Observational

Primary Outcome

Survival

Secondary Outcome

 Toxicity

Condition

Mesothelioma

Intervention

Chemotherapy

Study Arms / Comparison Groups

 Chemotherapy

Description:  intraarterial chemotherapy with cisplatin and mitoxantrone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2009

Completion Date

May 2015

Primary Completion Date

January 2015

Eligibility Criteria

        Inclusion Criteria:

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

        Exclusion Criteria:

          -  Drug abuse, distant metastases, no bone marrow function

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Karl R. Aigner, MD, ,

Administrative Informations

NCT ID

NCT02467426

Organization ID

Responsible Party

Principal Investigator

Study Sponsor

Medias Klinikum for Surgical Oncology

Study Sponsor

Karl R. Aigner, MD, Principal Investigator, Medias Klinikum Burghausen

Verification Date

June 2015