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Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, January 2002
First Received: January 30, 2002   Last Updated: June 23, 2005   History of Changes
Sponsor: FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00030069
  Purpose

This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: Calcitriol
Drug: Dexamethasone
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Safety/Efficacy Study
Official Title: Calcitriol and Dexamethasone for Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 60
Study Start Date: September 2001
Estimated Study Completion Date: September 2004
Detailed Description:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030069

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert L. Redner, M.D.     412-624-9598     redner+@pitt.edu    
Principal Investigator: Robert L. Redner, M.D.            
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: FD-R-2025-01, FD-R-002025-01
Study First Received: January 30, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00030069     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Hematopoiesis
Apoptosis
Cell Differentiation
Bone Marrow Cells

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Bone Density Conservation Agents
Hormones
Calcitriol
Membrane Transport Modulators
Preleukemia
Pathologic Processes
Vitamins
Syndrome
Therapeutic Uses
Vasoconstrictor Agents
Micronutrients
Dexamethasone acetate
Disease
Antineoplastic Agents, Hormonal
Hematologic Diseases
Growth Substances
Myelodysplastic Syndromes
Gastrointestinal Agents
Cardiovascular Agents
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009