Expired Study
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Sioux Falls, South Dakota 57104


Purpose:

RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably. PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.


Study summary:

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.


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


NCT ID:

NCT00002996


Primary Contact:

Study Chair
Charles F. Von Gunten, MD, PhD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Sioux Falls, South Dakota 57104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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