Paricalcitol in Treating Patients With Myelodysplastic Syndrome

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status and phase

Completed
Phase 2

Conditions

Leukemia
Myelodysplastic Syndromes

Treatments

Drug: paricalcitol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00064376
CSMC-IRB-4107-01
CDR0000315451

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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