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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

Clinicaltrials.gov identifier NCT03943498

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted August 6, 2020

Study Description

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.

  • Condition or Disease:Chemotherapy-Induced Peripheral Neuropathy
    Numbness
    Pain
    Tingling
  • Intervention/Treatment: Drug: Fingolimod
    Drug: Fingolimod Hydrochloride
    Other: Questionnaire Administration
  • Phase: Early Phase 1
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Treatment of Established Chemotherapy-Induced Neuropathy With Fingolimod: A Pilot Trial
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
Arm Intervention/treatment
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
Given PO daily for 4 weeks

Drug: Fingolimod Hydrochloride
Given PO

Other: Questionnaire Administration
Ancillary studies
Outcome Measures
  • Primary Outcome Measures: 1. Serially measured total sensory neuropathy scores [ Time Frame: Baseline up to 3 months post treatment ]
    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.
  • Secondary Outcome Measures: 1. Incidence of adverse events (AEs) of fingolimod [ Time Frame: Up to 4 weeks ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 == 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 == 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.

Contacts and Locations
Contacts
Locations

United States, Minnesota
Mayo Clinic
Rochester

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator: Charles L Loprinzi Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03943498 History of Changes
  • Other Study ID Numbers: MC18C2, NCI-2019-02742, MC18C2, P30CA015083
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: August 6, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Peripheral Nervous System Diseases