Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030069
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2002-01-30
Brief Title:
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Calcitriol and Dexamethasone for Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002025-01 | None | None | None |