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Home > "C" Clinical Trials Conditions > Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes  Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
For Condition: Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.
Details: Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results. This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS) - Evidence of cytopenia affecting at least 1 hematological cell lineage - Adequate liver and renal function - ECOG 0-2 - Expected survival of at least 12 weeks Exclusion criteria: - Symptomatic coronary artery disease - Uncontrolled diabetes mellitus - Uncontrolled and symptomatic glaucoma - History of dangerous reactions to steroid therapy - Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks - History of nephrolithiasis - Children - Chronic myelomonocytic leukemia (CMML)
Total Enrollment: 60
Location and Contact Information:
University of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Robert Redner 412-624-9598
Additional Information:
Study ID Numbers: FD-R-2025-01; FD-R-002025-01
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030069
Other Myelodysplastic Syndromes Studies:
1. Bevacizumab in Treating Patients With Myelodysplastic Syndrome
2. Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
3. Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
4. Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
5. Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
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