Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

NCT03943498 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: MC18C2NCI-2019-02742P30CA015083
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Numbness; Pain; Tingling

Outcome Measures

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.

  Baseline up to 3 months post treatment

Secondary Outcomes (1)

• Incidence of adverse events (AEs) of fingolimod

  Up to 4 weeks

Study Arms (1)

Treatment (Fingolimod)

EXPERIMENTAL

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

Fingolimod DRUG

Given PO daily for 4 weeks

Treatment (Fingolimod)

Fingolimod Hydrochloride DRUG

Given PO

Also known as: FTY-720, FTY720, Gilenya

Treatment (Fingolimod)

Questionnaire Administration OTHER

Ancillary studies

Treatment (Fingolimod)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypesthesia; Pain; Paresthesia

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Charles L Loprinzi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: May 24, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

US (2)