Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064376
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2003-07-08
Brief Title:
Paricalcitol in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2018-01
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:
RATIONALE Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells
PURPOSE Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes
Determine whether this drug can improve RBC WBC or platelet counts in these patients
Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients
OUTLINE Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 8 months
Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes
Determine whether this drug can improve RBC WBC or platelet counts in these patients
Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients
OUTLINE Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CSMC-IRB-4107-01 | None | None | None |