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| 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 |
| 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) |
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 |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| 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 |
|
Hematopoiesis Apoptosis Cell Differentiation Bone Marrow Cells |
|
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 |