This is a Phase I clinical trial evaluating the combination of hydroxyurea and magnesium pidolate for patients with sickle cell disease with either hemoglobin SS disease or hemoglobin S beta thalassemia. Hydroxyurea and magnesium pidolate will be tested in pediatric and adolescent patients with sickle cell disease who already have been treated with hydroxyurea for a minimum of six months. Magnesium pidolate will be given in combination with hydroxyurea for six months. In successive small groups of patients, the dose of magnesium will be increased in order to eventually determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for magnesium when given in combination with hydroxyurea. The maximum tolerated dose is the highest drug dose that can be given safely to participants. The dose limiting toxicity is determined when drug side effects prevent an increase in dose.

Condition	Intervention	Phase
Anemia, Sickle Cell	Drug: Magnesium Pidolate, Hydroxyurea	Phase I

Further Study Details: 

Primary Outcomes: To estimate the maximum tolerated dose of magnesium pidolate in combination with hydroxyurea in patients with sickle cell disease who have been on a therapeutic dose of hydroxyurea for at least six months.; To document the toxicity of the combination of hydroxyurea and magnesium pidolate.; To investigate the effect of the combination of hydroxyurea and magnesium on hematological parameters and red cell metabolism.
Expected Total Enrollment:  20

Ages Eligible for Study:  3 Years   -   15 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Greater than or equal to 3 years of age and less than 15 years of age.
• Diagnosis of Hemoglobin SS disease or sickle beta-zero thalassemia.
• Adequate kidney and liver function.
• Treatment with hydroxyurea for at least six months prior to study entry.

Exclusion Criteria:

-

Please refer to this study by ClinicalTrials.gov identifier  NCT00143572

Winfred Wang, M.D.      1-866-278-5833    info@stjude.org

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting

Study chairs or principal investigators

Winfred Wang, M.D.,  Principal Investigator,  St. Jude Children''''s Research Hospital   

Study ID Numbers:  HUMG1
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143572
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06