Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

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

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: BB 1101; Calcitriol; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion criteria:

• Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS)

• Evidence of cytopenia affecting at least 1 hematological cell lineage

• Adequate liver and renal function

• ECOG 0-2

• Expected survival of at least 12 weeks

Exclusion criteria:

• Symptomatic coronary artery disease

• Uncontrolled diabetes mellitus

• Uncontrolled and symptomatic glaucoma

• History of dangerous reactions to steroid therapy

• Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks

• History of nephrolithiasis

• Children

• Chronic myelomonocytic leukemia (CMML)