Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Malignant (Pleural) Mesothelioma
- Mesothelioma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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).
Tracking Information
- NCT #
- NCT02611037
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bela Kis, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
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