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Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
This study has been completed.

First Received on January 30, 2002.   Last Updated on June 1, 2010   History of Changes
Sponsor: University of Pittsburgh
Collaborator: FDA Office of Orphan Products Development
Information provided by: University of Pittsburgh
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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calcitriol and Dexamethasone for Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 60
Study Start Date: September 2001
Study Completion Date: May 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Robert Redner, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00030069     History of Changes
Other Study ID Numbers: UPCI 01-020, FD-R-002025-01
Study First Received: January 30, 2002
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Hematopoiesis
Apoptosis
Cell Differentiation
Bone Marrow Cells

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Calcitriol
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012