CClinicalTrials.gg
CompletedNCT03943498Updated Sep 11, 2023

Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

An Early Phase 1 interventional study of Fingolimod and Fingolimod Hydrochloride in Chemotherapy-Induced Peripheral Neuropathy, Numbness and Pain, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was Dec 2020, 5 years 9 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Chemotherapy-Induced Peripheral Neuropathy
  • Numbness
  • Pain
  • Tingling
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Treatment (Fingolimod)

    Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks. Take your Fingolimod approximately every 24 hours

    Drug: Fingolimod · Drug: Fingolimod Hydrochloride · Other: Questionnaire Administration

Interventions

  • DrugFingolimod

    Given PO daily for 4 weeks

  • DrugFingolimod Hydrochloride

    Given PO

    Also known as: FTY-720, FTY720, Gilenya

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. Serially measured total sensory neuropathy scores

    Will be obtained from the 6 individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). The hypothesis will be tested with the two-sided one-sample t-test at a significance level of 10% reduction. In the event that the distribution of the within-patients change from baseline in total sensory neuropathy scores is not approximately normally distributed, then variable transformation or a nonparametric one-sample Wilcoxon signed-rank test will be considered as alternative approaches.

    Time frame: Baseline up to 3 months post treatment

Secondary outcomes

  1. Incidence of adverse events (AEs) of fingolimod

    The constellation of AEs as scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) will be summarized by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles, the maximum grade for each type of AE are recorded for each patient and data listings and frequency tables are clinically reviewed to determine overall patterns, including AE attribution (possible, probable, and definite) to fingolimod. Sensory neuropathy will be graded as none, mild, moderate, and severe. The percentage of patients experiencing an improvement in sensory neuropathy from baseline using NCI CTCAE v5.0 will be calculated with the exact 90% confidence interval.

    Time frame: Up to 4 weeks

07

Study locations

2 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • The Ohio State University
    Columbus, Ohio 43212, United States
08

References and documents

Study documents

  • Informed consent form · Mar 10, 2021

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03943498
Lead sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 9, 2019
Start date
May 24, 2019
Primary completion
Dec 10, 2020
Completion
Dec 10, 2020
Last update
Sep 11, 2023

Study contacts

Charles L Loprinzi
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion