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Paricalcitol in Treating Patients With Myelodysplastic Syndrome



Paricalcitol in Treating Patients With Myelodysplastic Syndrome

For Condition: Chronic Myelomonocytic Leukemia,Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): Cedars-Sinai Medical Center ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 25 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
H.Koeffler,  Study Chair,  Cedars-Sinai Medical Center

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting H.  Koeffler 310-423-4609


Additional Information:
Study ID Numbers:  CDR0000315451;  CSMC-IRB-4107-01
Study Start Date: 
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064376

Other Chronic Myelomonocytic Leukemia Studies:
1. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia

2. Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

3. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes

4. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma

5. Decitabine in Treating Patients With Myelodysplastic Syndrome

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Paricalcitol in Treating Patients With Myelodysplastic Syndrome
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