A Study to Evaluate Prevention of Paclitaxel-Associated Neuropathy with Fingolimod
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-000917
NCT ID: NCT03941743
Sponsor Protocol Number: MC18C1
About this study
The purpose of this study is to determine if the use of Gilenya® can reduce neuropathy caused by paclitaxel.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age ≥ 18 years.
- Ability to complete questionnaires by themselves or with assistance.
- Paclitaxel at a dose of 80 mg/m^2 given every week for a scheduled course of 12 weeks for treating breast cancer.
- Life expectancy ≥ 6 months.
- ECOG Performance Status (PS) 0, 1.
- Negative pregnancy test (serum or urine) done ≤ 14 days prior to registration, for persons of childbearing potential only.
- Provide written informed consent.
- Previous exposure to paclitaxel (please note that it is acceptable for patients to receive non-neurotoxic chemotherapy, like AC, before or after the weekly paclitaxel and/or to receive concurrent anti-her 2 therapy).
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant persons;
- Nursing persons;
- Persons of childbearing potential who are unwilling to employ adequate contraception.
- Previous diagnosis of diabetic or other peripheral neuropathy.
- Current or previous use of fingolimod.
- History of the following preexisting conditions: ischemic heart disease, cardiac arrest, cerebrovascular disease, uncontrolled hypertension, symptomatic bradycardia, macular edema, recurrent syncope, severe untreated sleep apnea, herpes zoster, chronic hepatitis, tuberculosis, systemic fungal infections, skin cancer, or insulin-dependent diabetes.
- Myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure < 6 months prior to registration.
- History or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker.
- History of a hypersensitivity reaction to fingolimod or any of the excipients including rash, urticarial, and angioedema upon treatment initiation.
- Baseline QTC interval ≥ 450 ms (on EKG).
- Concurrent use of a class Ia or III antiarrhythmic.
- Drugs with a KNOWN risk of torsades de pointes (Information regarding drug specific risk of QT prolongation can be found at www.crediblemeds.org).
- Concurrent use of beta blockers, calcium channel blockers or digoxin.
- Use of immunosuppressive, or immune-modulating therapies that may have immunosuppressive effects.
- Immunocompromised patients including patients known to be HIV positive.
- Uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection;
- unstable angina pectoris;
- cardiac arrhythmia;
- psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent.
- Family history of a genetic/familial neuropathy.
- Received a vaccine (inactivated) ≤ 14 days prior to registration.
- Positive varicella zoster IgM titer, consistent with recent exposure.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Charles Loprinzi, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available