Clinical Trial: Use of Hydroxyurea and Magnesium Pidolate for Treatment of Sickle Cell Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: St. Jude Children's Research Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome:

  • 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.


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: St. Jude Children's Research Hospital

Dates:
Date Received: September 1, 2005
Date Started: November 2004
Date Completion:
Last Updated: April 24, 2017
Last Verified: February 2010