A Study to Evaluate Treatment of Established Chemotherapy-induced Neuropathy with Fingolimod

Overview

About this study

The purpose of this study is to determine if the use of Fingolimod can reduce neuropathy caused by chemotherapy.

Participation eligibility

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.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Pain or symptoms of CIPN of ≥ 3 months duration, for which the patient wants intervention.
    • NOTE: Neurotoxic chemotherapy must have been completed ≥ 3 months (93 days) prior to registration and there must be no further planned neurotoxic chemotherapy for > 2 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 utilizing question in Appendix VI).
  • 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, 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 hypersensitivity reaction to fingolimod or any of the excipients including rash, urticarial, and angioedema upon treatment initiation.
  • Baseline QTc interval ≥ 450 ms (on patient 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 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.
  • 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 Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Stephan Thome, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20458951

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