Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030069
Recruitment Status : Completed
First Posted : January 31, 2002
Last Update Posted : January 15, 2016
Information provided by (Responsible Party):
Robert Redner, MD, University of Pittsburgh

January 30, 2002
January 31, 2002
January 15, 2016
September 2001
September 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00030069 on Archive Site
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Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
Calcitriol and Dexamethasone for Myelodysplastic Syndromes
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

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.

Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndromes
  • Drug: Calcitriol
  • Drug: Dexamethasone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2009
September 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
UPCI 01-020
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Robert Redner, MD, University of Pittsburgh
University of Pittsburgh
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University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP