Malignant Pleural MesotheliomaPhase 2NCT02611037
Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma
A Phase 2 study testing Cisplatin, Methotrexate and Gemcitabine in people with Malignant Pleural Mesothelioma and Mesothelioma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma, Mesothelioma
- What is being tested?
- Cisplatin, Methotrexate and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2016to 26 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histologically or cytologically confirmed malignant pleural mesothelioma (MPM).
- Have unresectable MPM or the patient refuses surgery for resectable MPM.
- Have failed to respond first line standard of care chemotherapy or the patient refuses first line chemotherapy.
- Have measurable disease, by computed tomography (CT) or magnetic resonance imaging (MRI) per modified Response Evaluation Criteria in Solid Tumors (RECIST) for mesothelioma. Radiographic tumor assessment must be performed within 28 days prior to the first treatment.
- The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%).
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- All baseline laboratory requirements will be assessed and should be obtained within 14 days of first treatment. Screening laboratory values must be met..
- Women participate in the study must be surgically sterile, post-menopausal, or women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation and after for a certain amount of time (up to 5 weeks) after the last treatment.
- Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of transarterial chemoperfusion treatment.
- Men must be surgically sterile or must agree to use adequate contraception prior to study entry and for the duration of study participation and after for a certain amount of time (up to 14 weeks) after the last treatment.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must have signed and dated an Institutional Review Board (IRB) approved written informed consent form in accordance with regulatory and institutional guidelines.
- Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study.
- This study permits the re-enrollment of a participant who has discontinued the study for a reason other than treatment failure or adverse event(s) of the study treatment.
Who cannot join
- Patients who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Recovery means resolution to at least Grade 1 toxicity if there was no baseline toxicity or less than or equal to the patient's baseline value.
- May not be receiving any other investigational agents.
- Known brain metastases or leptomeningeal metastases. Patients with other extrapleural metastases are included in this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, methotrexate, gemcitabine or other agents used during the study. History of allergic reaction to intravenous iodinated contrast media is not contraindication to the study. Patients with history of mild allergic reaction to iodinated contrast media will be premedicated with 40 mg of prednisone by mouth (p.o.) 12 and 2 hrs before the transarterial chemoperfusion treatment to prevent allergic reaction. Patients with history of moderate and severe allergic reaction to iodinated contrast media or patients with history of mild allergic reaction to iodinated contrast media despite adequate premedication will undergo angiogram using carbon dioxide or a gadolinium based contrast agent.
- Uncontrolled intercurrent illness including, but not limited to, presence of other malignancy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Women who are pregnant or breastfeeding.
- HIV-positive patients receiving combination anti-retroviral therapy.
- Potential participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 22612
About this study
Official title: A Phase 2 Study of Transarterial Chemoperfusion Treatment With Cisplatin, Methotrexate and Gemcitabine in Patients With Unresectable Pleural Mesothelioma
The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM).
Read the detailed description
This is an open-label, single arm, phase 2 study with a lead in safety cohort to evaluate the safety and efficacy of transarterial chemoperfusion treatment with cisplatin (35 mg/m2^), methotrexate (100 mg/m^2) and gemcitabine (1000 mg/m^2) in patients with unresectable MPM. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m^2) and regular doses of cisplatin (35 mg/m^2 body surface area (BSA)) and gemcitabine (1000 mg/m^2 BSA).
- Conditions
- Malignant Pleural Mesothelioma, Mesothelioma
- Being tested
- Cisplatin, Methotrexate, Gemcitabine, Lung Cancer Symptom Scale for Mesothelioma Questionnaire
- Keywords
- MPM, Unresectable, Respiratory, Intrathoracic, Transarterial, Chemoperfusion
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol
The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin.
MethotrexateDrug
Also called Trexall, Rheumatrex
The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m^2).
GemcitabineDrug
Also called Gemzar
The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.
Lung Cancer Symptom Scale for Mesothelioma QuestionnaireOther
Also called Quality of Life Assessment
Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Chemoperfusion + Questionnaire | Experimental | Transarterial Chemoperfusion treatment with cisplatin (35 mg/m^2), methotrexate (100 mg/m^2) and gemcitabine (1000 mg/m^2).
Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease.
Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Receives: Drug: Cisplatin; Drug: Methotrexate; Drug: Gemcitabine; Other: Lung Cancer Symptom Scale for Mesothelioma Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Disease control rate of transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine in patients with unresectable malignant pleural mesothelioma using modified Response Evaluation Criteria in Solid Tumors (RECIST) for mesothelioma. DCR provided as percentage of participants with partial response + percentage of participants with stable disease.
Measured: Up to 3 years
Secondary outcomes (4)
Overall Survival (OS)
Overall survival defined as the time from the first day of transarterial chemoperfusion treatment to death.
Measured: Up to 3 years
Progression Free Survival (PFS)
Progression free survival defined as the time from the first day of transarterial chemoperfusion treatment to disease progression based on imaging findings using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for mesothelioma. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 3 years
Occurrence of Treatment Related Toxicity
Safety was assessed by monitoring adverse events and serious adverse events; the association with study treatment was assessed, and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) v.4.03. Number of events that were Possible, Probable or Definitely related to study treatment.
Measured: Up to 3 years
Quality of Life Questionnaire Scores
Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. Mesothelioma Symptom Scale includes 7 categories to rate on a scale of 1 to 10 regarding severity of symptoms during the last 24 hours. A higher number indicates more severe symptoms.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start4 Mar 2016
- Primary completion16 Oct 2021
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bela Kis, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611037
- Sponsor's protocol ID
- MCC-18094
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2015
- Last updated
- 18 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Transarterial Chemoperfusion Treatment With Cisplatin, Methotrexate and Gemcitabine in Patients With Unresectable Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT02611037
- Acronym / sponsor ID
- MCC-18094
- Conditions
- Malignant Pleural Mesothelioma, Mesothelioma
- Keywords
- MPM, Unresectable, Respiratory, Intrathoracic, Transarterial, Chemoperfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM).
Detailed description
This is an open-label, single arm, phase 2 study with a lead in safety cohort to evaluate the safety and efficacy of transarterial chemoperfusion treatment with cisplatin (35 mg/m2^), methotrexate (100 mg/m^2) and gemcitabine (1000 mg/m^2) in patients with unresectable MPM. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m^2) and regular doses of cisplatin (35 mg/m^2 body surface area (BSA)) and gemcitabine (1000 mg/m^2 BSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoperfusion + Questionnaire | Experimental | Drug: Cisplatin, Drug: Methotrexate, Drug: Gemcitabine, Other: Lung Cancer Symptom Scale for Mesothelioma QuestionnaireTransarterial Chemoperfusion treatment with cisplatin (35 mg/m^2), methotrexate (100 mg/m^2) and gemcitabine (1000 mg/m^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must have histologically or cytologically confirmed malignant pleural mesothelioma (MPM).
- Have unresectable MPM or the patient refuses surgery for resectable MPM.
- Have failed to respond first line standard of care chemotherapy or the patient refuses first line chemotherapy.
- Have measurable disease, by computed tomography (CT) or magnetic resonance imaging (MRI) per modified Response Evaluation Criteria in Solid Tumors (RECIST) for mesothelioma. Radiographic tumor assessment must be performed within 28 days prior to the first treatment.
- The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment.
Key exclusion criteria (8 listed)
- Patients who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Recovery means resolution to at least Grade 1 toxicity if there was no baseline toxicity or less than or equal to the patient's baseline value.
- May not be receiving any other investigational agents.
- Known brain metastases or leptomeningeal metastases. Patients with other extrapleural metastases are included in this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, methotrexate, gemcitabine or other agents used during the study. History of allergic reaction to intravenous iodinated contrast media is not contraindication to the study. Patients with history of mild allergic reaction to iodinated contrast media will be premedicated with 40 mg of prednisone by mouth (p.o.) 12 and 2 hrs before the transarterial chemoperfusion treatment to prevent allergic reaction. Patients with history of moderate and severe allergic reaction to iodinated contrast media or patients with history of mild allergic reaction to iodinated contrast media despite adequate premedication will undergo angiogram using carbon dioxide or a gadolinium based contrast agent.
- Uncontrolled intercurrent illness including, but not limited to, presence of other malignancy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| CisplatinAlso: PlatinolThe recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin. | Drug | Chemoperfusion + Questionnaire |
| MethotrexateAlso: Trexall, RheumatrexThe recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m^2). | Drug | Chemoperfusion + Questionnaire |
| GemcitabineAlso: GemzarThe recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine. | Drug | Chemoperfusion + Questionnaire |
| Lung Cancer Symptom Scale for Mesothelioma QuestionnaireAlso: Quality of Life AssessmentQuality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire. | Other | Chemoperfusion + Questionnaire |
Primary outcome
Disease Control Rate (DCR)
Time frame: Up to 3 years
Disease control rate of transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine in patients with unresectable malignant pleural mesothelioma using modified Response Evaluation Criteria in Solid Tumors (RECIST) for mesothelioma. DCR provided as percentage of participants with partial response + percentage of participants with stable disease.
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years
Progression Free Survival (PFS)
Time frame: Up to 3 years
Occurrence of Treatment Related Toxicity
Time frame: Up to 3 years
Quality of Life Questionnaire Scores
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Moffitt Cancer Center Clinical Trials websiteLink 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.
Bela Kis, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Methotrexate and Gemcitabine in people with Malignant Pleural Mesothelioma and Mesothelioma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 14 inclusion and 8 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Rate (DCR) (time frame: Up to 3 years). 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 18 Dec 2025.