May 9, 2019
November 13, 2020
This early phase I trial studies how well fingolimod works in treating patients with chemotherapy-induced nerve pain (neuropathy). Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by chemotherapy.
PRIMARY OBJECTIVES: I. To evaluate whether fingolimod markedly improves symptoms in patients with established (chemotherapy-induced peripheral neuropathy) CIPN. II. To evaluate the tolerability of fingolimod in these treated patients. OUTLINE: Patients receive fingolimod orally (PO) once daily (QD) for 4 weeks. After completion of study treatment, patients are followed up every month for 3 months.
|Experimental: Treatment (Fingolimod)
Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks. Take your Fingolimod approximately every 24 hours
Given PO daily for 4 weeks
Drug: Fingolimod Hydrochloride
Other: Questionnaire Administration
- Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants
- NOTE: Neurotoxic chemotherapy must have been completed >= 6 months (186 days)
prior to registration and there must be no further planned neurotoxic
chemotherapy for > 6 months after registration.
- Tingling, numbness or pain was at least a four out of ten problem during the week
prior to registration, on a 0-10 scale where zero was no problem and ten was the worst
possible problem (patient verbal report to clinician).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2.
- Negative pregnancy test done == 6 months.
- 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
- 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 simplex virus
(HSV) varicella zoster (VZV), chronic hepatitis, tuberculosis, fungal infections, skin
cancer, or diabetes.
- Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA),
decompensated heart failure requiring hospitalization or class III/IV heart failure == 450 ms (on patient electrocardiography [EKG]).
- Concurrent use of a class Ia or III antiarrhythmic drug.
- Drugs with a known risk of torsades de pointes.
- Concurrent use of beta blockers, calcium channel blockers, or digoxin.
- Use of immunosuppressive or immune-modulating therapies that may have
- Immunocompromised patients including patients known to be human immunodeficiency virus
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection.
- Unstable angina pectoris.
- Cardiac arrhythmia.
- Or psychiatric illness/social situations that would limit compliance with study
- Family history of genetic/familial neuropathy.
- Currently receiving another agent to treat CIPN, such as duloxetine, gabapentin or
pregabalin, and not willing to be weaned off of these medications prior to therapy
- History of peripheral neuropathy prior to receiving neurotoxic chemotherapy.
- Received a vaccine (inactivated) =< 2 weeks prior to registration.
United States, Minnesota
United States, Ohio
The Ohio State University
National Cancer Institute (NCI)
Principal Investigator: Charles L Loprinzi Mayo Clinic