Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

NCT ID: NCT03943498

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2020-12-10

Brief 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.

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Numbness; Pain; Tingling

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment (Fingolimod)

Patients receive 0.5 mg dose of Fingolimod PO QD for 4 weeks.

Take your Fingolimod approximately every 24 hours

Group Type: EXPERIMENTAL

Fingolimod

Intervention Type: DRUG

Given PO daily for 4 weeks

Fingolimod Hydrochloride

Intervention Type: DRUG

Given PO

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Fingolimod

Given PO daily for 4 weeks

Intervention Type: DRUG

Fingolimod Hydrochloride

Given PO

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

FTY-720; FTY720; Gilenya

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles L Loprinzi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2019-02742

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC18C2

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC18C2

Identifier Type: -

Identifier Source: org_study_id