Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    10
  • sponsor
    Mayo Clinic
Updated on 26 January 2021
paresthesia
numbness

Summary

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.

Description

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.

Details
Condition Hypoesthesia, Paresthesia, Pain, Acute Pain Service, Post-Surgical Pain, Chemotherapy Induced Peripheral Neuropathy, Pain (Pediatric), tingling, abnormal sensation, paresthesias, paraesthesia, ache, tingling sensation, numbness, loss of sensation
Treatment questionnaire administration, Fingolimod, Fingolimod Hydrochloride
Clinical Study IdentifierNCT03943498
SponsorMayo Clinic
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: tingling or Acute Pain Service or Hypoesthesia or Pain or Chemotherapy Induced Peripheral Neuropathy or Pain (Pediatric) or Post-Surgical Pain?
Do you have any of these conditions: Paresthesia or tingling sensation or ache or Post-Surgical Pain or Pain (Pediatric) or tingling or paresthesias or Pain or loss of sensation or Chemot...?
Do you have any of these conditions: paraesthesia or tingling or Acute Pain Service or paresthesias or ache or Paresthesia or abnormal sensation or loss of sensation or tingling sensation...?
Do you have any of these conditions: abnormal sensation or Hypoesthesia or ache or Chemotherapy Induced Peripheral Neuropathy or Pain or paresthesias or Post-Surgical Pain or paraesthesia...?
Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention
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 =< 14 days prior to registration, for persons of childbearing potential only
Provided written informed consent
Ability to complete questionnaire(s) by themselves or with assistance
Life expectancy >= 6 months

Exclusion Criteria

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 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 =< 6 months prior to registration
History or presence of Mobitz type II second degree or third degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker
History of hypersensitivity reaction to fingolimod or any of the excipients including rash, urticarial, and angioedema upon treatment initiation
Baseline corrected QT (QTc) interval >= 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 immunosuppressive effects
Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive
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 requirements
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 initiation
History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
Received a vaccine (inactivated) =< 2 weeks prior to registration
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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