A Study to Evaluate Prevention of Paclitaxel-Associated Neuropathy with Fingolimod

Overview

About this study

The purpose of this study is to determine if the use of Gilenya® can reduce neuropathy caused by paclitaxel.

 

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions