Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes

PROTOCOL OUTLINE:

Patients receive oral hydroxyurea either once or twice daily plus oral clotrimazole twice
daily after meals for 6 months. Patients are assessed at 3 and 6 months during treatment.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Sickle cell syndromes characterized by vaso-occlusive crises
sufficiently severe to require prophylactic therapy Three or more crises per year
sufficiently severe to require hospitalization Stable dose of hydroxyurea for at least 4
months required --Prior/Concurrent Therapy-- No treatment with any other antisickling
agents within the past 4 months Biologic therapy: No transfusion within 90 days No
concurrent chronic transfusions allowed (defined as more than one transfusion per month
for 2 or more months) Chemotherapy: See Disease Characteristics Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: No chronic medications
that alter neurologic, renal, or hepatic functions

- Patient Characteristics-- Performance status: Karnofsky 70-100%
Hematopoietic: WBC within normal limits Platelet count within normal limits Hepatic:
No history of chronic liver disease Bilirubin less than 2 times normal SGOT and SGPT
less than 2.5 times normal No severe hepatic damage Renal: Creatinine within normal
limits No severe renal damage Neurologic: No severe neurologic impairment No recent
or progressive neurologic impairment Other: Not pregnant Fertile patients must use
effective contraception No allergies to hydroxyurea or clotrimazole