Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
OBJECTIVES:

 Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific
 panel of red cell characteristics 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.

 Completion date provided represents the completion date of the grant per OOPD records
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