- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03941743
Recruitment Status Recruiting
First Posted May 8, 2019
Last update posted August 5, 2020
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.
PRIMARY OBJECTIVES: I. To obtain preliminary data to support whether fingolimod hydrochloride (fingolimod) will prevent chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving weekly adjuvant/neoadjuvant paclitaxel therapy. SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible relative toxicities related to fingolimod therapy in this study situation. OUTLINE: Patients receive fingolimod hydrochloride orally (PO) once daily (QD) starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks. After the completion of study, patients are followed up at 6, 12, and 18 months.
|Experimental: Prevention (fingolimod hydrochloride)
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 Hydrochloride
Other: Questionnaire Administration
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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. Exclusion Criteria: - 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 = 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.
- Use of immunosuppressive, or immune-modulating therapies that may have
- Immunocompromised patients including patients known to be human immunodeficiency virus
- 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
- Receiving any other investigational agent.
- Family history of a genetic/familial neuropathy.
- Received a vaccine (inactivated) =< 14 days prior to registration.
United States, Minnesota
United States, Virginia
Virginia Commonwealth University/ Massey Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Charles L Loprinzi Mayo Clinic