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).
|First Received Date||November 18, 2015|
|Last Changed Date||December 12, 2017|
|Start Date||January 4, 2016|
|Anticipated Primary Completion Date||December 2018|
|Primary Outcome Measures||
Objective Response Rate (ORR) [Time Frame: Up to 3 years]
|Secondary Outcome Measures||
Overall Survival (OS) [Time Frame: Up to 3 years]
Progression Free Survival (PFS) [Time Frame: Up to 3 years]
Occurrence of Treatment Related Toxicity [Time Frame: Up to 3 years]
Quality of Life Questionnaire Scores [Time Frame: Up to 3 years]
|Study Arms / Comparison Groups||1 / 0|
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).
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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.
- 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.
|Sponsor||H. Lee Moffitt Cancer Center and Research Institute|
|Verification Date||December 2017|