Flecainide in Treating Patients With Chronic Neuropathic Pain

RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.

Official Title

Phase II Study of Flecainide for the Treatment of Chronic Neuropathic Pain

Conditions

– Pain

Study Type

Interventional

Study Design

Treatment

Further Details

OBJECTIVES:Investigate the effectiveness of flecainide in the management of neuropathic pain. OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain. PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.

Study Start

Eligibility & Criteria

Ages Eligible for Study: 19 Years and above, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS:Chronic neuropathic pain with diagnosis of cancer or AIDS PATIENT CHARACTERISTICS: Age:Over 18 Performance status:Not specified Life expectancy:Not specified Hematopoietic:Not specified Hepatic:SGOT no greater than 2 times upper limit of normal (ULN) Renal:Creatinine no greater than 2 times ULN Cardiovascular:No clinical history of infarction or angina No advanced heart failure No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult) No focal wall motion abnormalities Ejection fraction at least 40% Systolic blood pressure at least 90 mm Hg Other:Must be able to take oral medication No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy:Not specified Chemotherapy:At least 2 weeks since prior chemotherapy that may cause neuropathy Endocrine therapy:At least 2 weeks since prior corticosteroids Radiotherapy:Not specified Surgery:Not specified Other:No tricyclic antidepressant treatment within past 2 weeks No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug

Total Enrolment

Contact Details

[1] Charles F. Von Gunten, MD, PhD, Study Chair, Robert H. Lurie Cancer Center [2] Eastern Cooperative Oncology Group[3] National Cancer Institute (NCI)