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Isolated Thoracic Perfusion (ITP-F) for MPM

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ClinicalTrials.gov Identifier: NCT02467426
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Andreas Sendler, Medias Klinikum for Surgical Oncology

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.

Condition or disease Intervention/treatment
Mesothelioma 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.


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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Isolated Thoracic Perfusion With Hemofiltration (ITP-F) for Pretreated and Progressive Malignant Pleural Mesothelioma
Study Start Date : September 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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




Primary Outcome Measures :
  1. Survival [ Time Frame: one year survival ]
    Kaplan-Maier Plot


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 4 weeks after therapy ]
    Toxicity was measured by Common Toxicity Criteria Vers. 2.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with progressive malignant mesothelioma after failure of convetional multimodal therapy including resection
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Drug abuse, distant metastases, no bone marrow function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467426


Sponsors and Collaborators
Medias Klinikum for Surgical Oncology
Investigators
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Principal Investigator: Karl R. Aigner, MD Medias Klinikum Burghausen

Additional Information:
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Responsible Party: Prof. Andreas Sendler, Senior Consultant, Dept. of Surgical Oncology, Medias Klinikum for Surgical Oncology
ClinicalTrials.gov Identifier: NCT02467426     History of Changes
Other Study ID Numbers: 0001
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by Prof. Andreas Sendler, Medias Klinikum for Surgical Oncology:
Mesothelioma, malignant
Chemotherapy
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action