Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paricalcitol in Treating Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00064376
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
H. Phillip Koeffler, Cedars-Sinai Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: paricalcitol Phase 2

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Abbott
Investigators
Layout table for investigator information
Study Chair: H. Phillip Koeffler, MD Cedars-Sinai Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: H. Phillip Koeffler, Director, Medicine / Hematology/Oncology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00064376     History of Changes
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Phillip Koeffler, Cedars-Sinai Medical Center:
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:
Layout table for MeSH terms
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
 Ergocalciferols
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents