Isolated Thoracic Perfusion (ITP-F) for MPM

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

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.

Study Overview

• Status: Completed
• Conditions: Mesothelioma
• Intervention / Treatment: Drug: Chemotherapy

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
• Enrollment (Actual): 23

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with progressive malignant mesothelioma after failure of convetional multimodal therapy including resection

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Drug abuse, distant metastases, no bone marrow function

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemotherapy; intraarterial chemotherapy with cisplatin and mitoxantrone	Drug: Chemotherapy; intraarterial infusion of cisplatin and mithoxantrone; Other Names: CDDP; Mitoxantrone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Kaplan-Maier Plot	one year survival

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Toxicity was measured by Common Toxicity Criteria Vers. 2.0	4 weeks after therapy

Collaborators and Investigators

• Sponsor: Medias Klinikum for Surgical Oncology
• Investigators: Principal Investigator: Karl R. Aigner, MD, Medias Klinikum Burghausen

Publications and helpful links

Helpful Links

• homepage of the hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Chemotherapy; Mesothelioma, malignant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma; Mesothelioma, Malignant; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Mitoxantrone
• Other Study ID Numbers: 0001 (Researcher)