Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
OBJECTIVES:

 I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the
 severity of anemia and the rate of hemolysis in patients with sickle cell anemia.
PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment
 arms.

 Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months.

 Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6
 weeks.

 Completion date provided represents the completion date of the grant per OOPD records
PROTOCOL ENTRY CRITERIA:

 --Disease Characteristics--

 Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis

 Received hydroxyurea for at least 6 months On a stable dose for at least 3 months
 Tolerating dose of at least 5 mg/kg/day

 --Prior/Concurrent Therapy--

 Chemotherapy:

 -  No other concurrent antisickling agent

 Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea
 or clotrimazole

 --Patient Characteristics--

 Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less
 than 11 g/dL

 Hepatic: AST/ALT no greater than 100 units/L

 Renal: Creatinine no greater than 1.5 mg/dL

 Other:

 -  Not pregnant or nursing

 -  Fertile patients must use effective contraception

 -  No prior adverse reaction to hydroxyurea or clotrimazole

 -  No recent or progressive neurologic dysfunction