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	Treatment or Intervention
Sickle Cell Anemia	Drug: clotrimazole  Drug: hydroxyurea

Further Study Details: 

Expected Total Enrollment:  20

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.

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 clotrimazole

Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
      Children's Hospital - Boston, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Carlo Brugnara,  Study Chair,  Children's Hospital Boston   

Study ID Numbers:  199/13288; CH-B-97-052; CH-B-FDR001022
Record last reviewed:  May 1998
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004404
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08