MesotheliomaNCT02467426
Isolated Thoracic Perfusion (ITP-F) for MPM
An observational study of Mesothelioma, run by Medias Klinikum for Surgical Oncology.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with progressive malignant mesothelioma after failure of convetional multimodal therapy including resection
Who may be able to join
- History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging
Who cannot join
- Drug abuse, distant metastases, no bone marrow function
About this study
Official title: 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.
Read the 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
- Being tested
- Chemotherapy
- Keywords
- Mesothelioma, malignant, Chemotherapy
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called CDDP, Mitoxantrone
intraarterial infusion of cisplatin and mithoxantrone
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | intraarterial chemotherapy with cisplatin and mitoxantrone Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Kaplan-Maier Plot
Measured: one year survival
Secondary outcomes (1)
Toxicity
Toxicity was measured by Common Toxicity Criteria Vers. 2.0
Measured: 4 weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startSep 2009
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medias Klinikum for Surgical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Andreas Sendler, Medias Klinikum for Surgical Oncology
- Investigators
- Karl R. Aigner, MD, Principal investigator, Medias Klinikum Burghausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467426
- Sponsor's protocol ID
- 0001
- Status last verified
- Jun 2015
- First submitted
- 26 May 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Thoracic Perfusion With Hemofiltration (ITP-F) for Pretreated and Progressive Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT02467426
- Acronym / sponsor ID
- 0001
- Conditions
- Mesothelioma
- Keywords
- Mesothelioma, malignant, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medias Klinikum for Surgical OncologyUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | Drug: Chemotherapyintraarterial chemotherapy with cisplatin and mitoxantrone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with progressive malignant mesothelioma after failure of convetional multimodal therapy including resection
Key inclusion criteria (1 listed)
- History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging
Key exclusion criteria (1 listed)
- Drug abuse, distant metastases, no bone marrow function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: CDDP, Mitoxantroneintraarterial infusion of cisplatin and mithoxantrone | Drug | Chemotherapy |
Primary outcome
Survival
Time frame: one year survival
Kaplan-Maier Plot
1 secondary outcome
Toxicity
Time frame: 4 weeks after therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- homepage of the hospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl R. Aigner, MD principal investigator
Medias Klinikum Burghausen
Questions about this trial
What is this clinical trial studying?
An observational study of Mesothelioma, run by Medias Klinikum for Surgical Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: one year survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.