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A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes


Phase 2
25 Years
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

H. Phillip Koeffler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000315451

NCT ID:

NCT00064376

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • 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
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048