Official Title: “Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial”

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 Type: Interventional

Study Design: Supportive Care

Study Primary Completion Date: December 2007

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.

Intervention(s) in this Clinical Trial

• Drug: flecainide acetate

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eastern Cooperative Oncology Group

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002996

Study ID Number: CDR0000065544

ClinicalTrials.gov Identifier: NCT00002996

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database