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Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paricalcitol
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia

Eligibility Criteria

25 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Clinical diagnosis of myelodysplastic syndromes according to the modified FAB classification Confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential Patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine PATIENT CHARACTERISTICS: Age 25 to 100 Performance status Karnofsky 60-100% Life expectancy At least 12 weeks Hematopoietic See Disease Characteristics Hepatic Bilirubin less than 2.0 mg/dL Renal Creatinine less than 2.5 mg/dL Calcium normal Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior sensitivity to paricalcitol or any component of its formulation No prior cholecalciferol toxicity No other concurrent acute illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 5 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy More than 5 weeks since prior radiotherapy Surgery Prior recent surgery allowed, if fully recovered Other More than 5 weeks since prior megadose vitamins No concurrent cholecalciferol, phosphate, calcium, or cholestyramine No concurrent digoxin

Sites / Locations

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2003
Last Updated
January 25, 2018
Sponsor
Cedars-Sinai Medical Center
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00064376
Brief Title
Paricalcitol in Treating Patients With Myelodysplastic Syndrome
Official Title
A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2003 (Actual)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paricalcitol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Clinical diagnosis of myelodysplastic syndromes according to the modified FAB classification Confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential Patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine PATIENT CHARACTERISTICS: Age 25 to 100 Performance status Karnofsky 60-100% Life expectancy At least 12 weeks Hematopoietic See Disease Characteristics Hepatic Bilirubin less than 2.0 mg/dL Renal Creatinine less than 2.5 mg/dL Calcium normal Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior sensitivity to paricalcitol or any component of its formulation No prior cholecalciferol toxicity No other concurrent acute illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 5 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy More than 5 weeks since prior radiotherapy Surgery Prior recent surgery allowed, if fully recovered Other More than 5 weeks since prior megadose vitamins No concurrent cholecalciferol, phosphate, calcium, or cholestyramine No concurrent digoxin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Phillip Koeffler, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

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Paricalcitol in Treating Patients With Myelodysplastic Syndrome

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