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Paricalcitol in Treating Patients With Myelodysplastic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2003
Last updated: July 23, 2008
Last verified: September 2004

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 Intervention Phase
Leukemia Myelodysplastic Syndromes Drug: paricalcitol Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2003
Detailed Description:


  • 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.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 25 to 100

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 12 weeks


  • See Disease Characteristics


  • Bilirubin less than 2.0 mg/dL


  • Creatinine less than 2.5 mg/dL
  • Calcium normal


  • 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


Biologic therapy

  • Not specified


  • More than 5 weeks since prior chemotherapy

Endocrine therapy

  • Not specified


  • More than 5 weeks since prior radiotherapy


  • Prior recent surgery allowed, if fully recovered


  • More than 5 weeks since prior megadose vitamins
  • No concurrent cholecalciferol, phosphate, calcium, or cholestyramine
  • No concurrent digoxin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00064376

United States, California
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Study Chair: H. Phillip Koeffler, MD Cedars-Sinai Medical Center
  More Information Identifier: NCT00064376     History of Changes
Other Study ID Numbers: CDR0000315451
Study First Received: July 8, 2003
Last Updated: July 23, 2008

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017