Paricalcitol in Treating Patients With Myelodysplastic Syndrome
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ClinicalTrials.gov Identifier: NCT00064376 |
Recruitment Status :
Completed
First Posted : July 9, 2003
Last Update Posted : January 29, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes | Drug: paricalcitol | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes |
Actual Study Start Date : | May 2003 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | November 2005 |


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Ages Eligible for Study: | 25 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064376
United States, California | |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 |
Study Chair: | H. Phillip Koeffler, MD | Cedars-Sinai Medical Center |
Responsible Party: | H. Phillip Koeffler, Director, Medicine / Hematology/Oncology, Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00064376 |
Other Study ID Numbers: |
CDR0000315451 CSMC-IRB-4107-01 |
First Posted: | July 9, 2003 Key Record Dates |
Last Update Posted: | January 29, 2018 |
Last Verified: | January 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes |
Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |