A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
25 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes
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 Center | Los Angeles, California 90048 |
