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Use of Hydroxyurea and Magnesium Pidolate for Treatment of Sickle Cell Disease

Anemia, Sickle Cell Clinical Trial

Official title:
Phase I Study of Combination Treatment With Hydroxyurea and Magnesium Pidolate in Patients With Sickle Cell Disease

Clinical Trial Summary

The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 months.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00143572
Study type Interventional
Source St. Jude Children's Research Hospital
Contact
Status Completed
Phase Phase 1
Start date November 2004
Completion date January 2008
View Details
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