For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
CLINICAL TRIAL- NCT02611037
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
Listing on www.clinicaltrials.gov
Sponsor: H. Lee Moffitt Cancer Study and Research Institute
Location: H Lee Moffitt Cancer Center and Research Institute Tampa, Florida
Principal Investigator: Bela Kis, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Contact: Malesa Pereira 1-888-663-3488 www.FloridaChestSurgery.com
Number of Participants: Expected to be about 36
Purpose:
This clinical trial is for patients who are not candidates for surgery, have disease progression, and pain. This is a palliative therapy to improve the quality of life of pleural mesothelioma patients who have unresectable recurrent pleural mesothelioma. The study is to determine whether transarterial chemoperfusion treatment with Cisplatin, Methotrexate and Gemcitabine in adult patients with malignant pleural mesothelioma is safe and at what dose.
Screening:
All baseline laboratory requirements will be assessed and should be obtained within 14 days of first treatment. Screening laboratory values must be met.
Must have histologically or cytological confirmed malignant pleural mesothelioma.
Have measurable disease, by a CT. scan or MRI. Radiological tumor assessment must be performed within 28 days prior to the first treatment.
Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of transarterial chemo perfusion treatment.
Men must be surgically sterile or must agree to use adequate contraception prior to the 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
Eligibility 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 chemotherapy suspended due to toxicity or other reasons.
• The predominant burden of disease lies in the arterial distribution which is accessible for transarterial chemo perfusion treatment.
• Men and Women greater than 18 years of age
• Eastern Cooperative Oncology Group performance status 60%
• 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.
The study permits the re-enrollment of a participant who has discontinued the study for a reason other than treatment failure or adverse event of the study treatment.
Patients with the 3 types of mesothelioma (epithelial, sarcomatoid and biphasic) are all eligible
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
• May not be receiving any other investigational agents
• Known brain metastases or leptomeningeal metastases. Patients with other extra pleural metastases are included in this study.
• History of allergic reactions to compounds similar to Cisplatin, Methotrexate, Gemcitabine
• Uncontrolled illness including 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 breast feeding
• Potential participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
How the Research Study Is Designed to Work:
Patients are given chemotherapy directly to the blood vessels feeding the tumor via a small catheter into the arteries feeding the tumor. The small catheter is placed temporarily into the femoral artery usually the groin of the patient, the catheter is fed up to the area of the tumor and then the chemotherapy is infused locally. By targeting the vessels feeding the tumor with chemotherapy agents it is hoped that the side-effects of the chemotherapy on the rest of the body are less. The process is repeated once a month.
Sources:
www.FloridaChestSurgery.com
www.ClinicalTrials.gov
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to contact us with any questions.
