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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02467426
Other study ID # 0001
Secondary ID
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


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
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