Paricalcitol in Treating Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: Abbott
• Treatments: Ergocalciferols

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