Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma
Condition: Malignant Pleural Mesothelioma; Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Cisplatin; Methotrexate; Gemcitabine; Lung Cancer Symptom Scale for Mesothelioma Questionnaire
Intervention description: 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.; 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).; 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.; Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
Intervention MeSH terms: Gemcitabine; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MPM; Unresectable; Respiratory; Intrathoracic; Transarterial; Chemoperfusion

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).
    

Eligibility criteria:

        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.