Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00030069
First received: January 30, 2002
Last updated: June 1, 2010
Last verified: May 2010

January 30, 2002
June 1, 2010
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 ClinicalTrials.gov 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030069
UPCI 01-020, FD-R-002025-01
Not Provided
Robert Redner, MD, University of Pittsburgh
University of Pittsburgh
FDA Office of Orphan Products Development
Not Provided
University of Pittsburgh
May 2010

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