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.

Condition	Treatment or Intervention	Phase
Pain	Drug: flecainide  Procedure: pain therapy  Procedure: supportive care/therapy	Phase II

Further Study 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.

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

Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000065544; ECOG-1Z95
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002996
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08