Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Serially measured total sensory neuropathy scores
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •Negative pregnancy test (serum or urine) done =< 14 days prior to registration, for persons of childbearing potential only.
- •Provide written informed consent.
排除标准
- •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.
- •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.
- •Receiving any other investigational agent.
- •Family history of a genetic/familial neuropathy.
- •Received a vaccine (inactivated) =< 14 days prior to registration.
研究组 & 干预措施
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.
干预措施: Fingolimod (Drug)
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.
干预措施: Fingolimod Hydrochloride (Drug)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Serially measured total sensory neuropathy scores
时间窗: Baseline up to 18 months
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.
次要结局
- Incidence of adverse events (AEs)(Up to 18 months)