Paricalcitol in Treating Patients With Myelodysplastic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00064376
First received: July 8, 2003
Last updated: July 23, 2008
Last verified: September 2004
  Purpose

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: 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:

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064376

Locations
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
Investigators
Study Chair: H. Phillip Koeffler, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00064376     History of Changes
Other Study ID Numbers: CDR0000315451, CSMC-IRB-4107-01
Study First Received: July 8, 2003
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Ergocalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014