Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer

NCT03941743 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: MC18C1NCI-2019-02741P30CA015083
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by paclitaxel.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Serially measured total sensory neuropathy scores

  Obtained from the 6 individual Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 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%. In the event that the distribution of the patient?s average 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 18 months

Secondary Outcomes (1)

• Incidence of adverse events (AEs)

  Up to 18 months

Study Arms (1)

Prevention (fingolimod hydrochloride)

EXPERIMENTAL

Patients receive fingolimod hydrochloride PO QD starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.

Drug: Fingolimod; Drug: Fingolimod Hydrochloride; Other: Questionnaire Administration

Interventions

Fingolimod DRUG

Given PO

Prevention (fingolimod hydrochloride)

Fingolimod Hydrochloride DRUG

Given PO

Also known as: FTY-720, FTY720, Gilenya

Prevention (fingolimod hydrochloride)

Questionnaire Administration OTHER

Ancillary studies

Prevention (fingolimod hydrochloride)

Eligibility Criteria

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

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (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.

You may not qualify if:

• Previous exposure to paclitaxel (please note that it is acceptable for patients to receive non-neurotoxic chemotherapy, like doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (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 simplex virus (HSV), varicella zoster virus (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 a 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 electrocardiography \[EKG\]).
• Concurrent use of a class Ia or III antiarrhythmic.
• Drugs with a known risk of torsades de pointes.
• Concurrent use of beta blockers, calcium channel blockers or digoxin.

Sponsors & Collaborators

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

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: December 12, 2019
• Primary Completion: June 5, 2020
• Study Completion: November 23, 2021
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (3)