Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

Myelodysplastic Syndromes Clinical Trial

Official title:

Calcitriol and Dexamethasone for Myelodysplastic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030069
• Other study ID #: UPCI 01-020
• Secondary ID: FD-R-002025-01
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2002
• Last updated: January 14, 2016
• Start date: September 2001
• Est. completion date: May 2009

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results.

This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Calcitriol

• Dexamethasone

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States,