A Phase 1 interventional study of Magnesium Pidolate, Hydroxyurea in Anemia, Sickle Cell, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by St. Jude Children's Research Hospital · Phase 1, Interventional, and Treatment
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.
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
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Drug: Magnesium Pidolate, Hydroxyurea
Intervention Description: 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. Mg pidolate will be given at an initial dose of 0.6 mEq/kg/day divided into 2 daily doses for the first cohort of patients. This dose will be escalated for the subsequent patient cohorts as defined by a classic Phase I design (according to toxicity).
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.
Time frame: Every 2 weeks for first 8 weeks; then every 4 weeks
To document the toxicity of the combination of hydroxyurea and magnesium pidolate.
Time frame: Every 2 weeks for first 8 weeks; then every 4 weeks
To investigate the effect of the combination of hydroxyurea and magnesium on hematological parameters and red cell metabolism.
Time frame: 3 months, 6 months, and 9 months
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital