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Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial


Phase 2
19 Years
N/A
Not Enrolling
Both
Pain

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Trial Information

Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Charles F. Von Gunten, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065544

NCT ID:

NCT00002996

Start Date:

February 1998

Completion Date:

Related Keywords:

  • Pain
  • pain
  • Neuralgia

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792