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Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00030069
Recruitment Status : Completed
First Posted : January 31, 2002
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Redner, MD, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: Calcitriol Drug: Dexamethasone Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcitriol and Dexamethasone for Myelodysplastic Syndromes
Study Start Date : September 2001
Actual Primary Completion Date : September 2007
Actual Study Completion Date : May 2009






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030069


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh

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Responsible Party: Robert Redner, MD, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00030069     History of Changes
Other Study ID Numbers: UPCI 01-020
FD-R-002025-01
First Posted: January 31, 2002    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Robert Redner, MD, University of Pittsburgh:
Hematopoiesis
Apoptosis
Cell Differentiation
Bone Marrow Cells
Additional relevant MeSH terms:
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Calcitriol
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators