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| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | September 2004 |
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| 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. | |
More Information
| 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 |
|
Hematopoiesis Apoptosis Cell Differentiation Bone Marrow Cells |
|
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 |