New chemo delivery method shows promise for tough mesothelioma cases
NCT ID NCT02611037
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to deliver chemotherapy directly to the tumor in adults with malignant pleural mesothelioma that cannot be removed by surgery. The treatment, called transarterial chemoperfusion, uses a combination of three drugs (cisplatin, methotrexate, and gemcitabine) to control the disease. The goal was to see if this approach is safe and effective at stopping the cancer from growing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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34 people
The number who actually took part.
- Started
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Mar 2016
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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%). * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 22612, United States
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