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Brief Title: Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma
Official Title: A Phase 2 Study of Transarterial Chemoperfusion Treatment With Cisplatin, Methotrexate and Gemcitabine in Patients With Unresectable Pleural Mesothelioma
Study ID: NCT02611037
Brief 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).
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Name: Bela Kis, M.D., Ph.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR