Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma
United States34 participantsStarted 2016-03-04
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 durati…
What they're measuring
1
Disease Control Rate (DCR)
Timeframe: Up to 3 years
Trial details
NCT IDNCT02611037
SponsorH. Lee Moffitt Cancer Center and Research Institute