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.

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. Condition:- Sickle Cell AnemiaStudy Type: InterventionalStudy Design: Treatment Further Study Details: 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. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria 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 clotrimazoleExpected Total Enrollment: 20[1] FDA Office of Orphan Products Development[2] Children’s Hospital Boston