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Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS)

NCT ID: NCT00057031

Last Updated: 2006-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-03-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.

Detailed Description

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DN-101 is an experimental drug that has not been approved by the Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. The natural vitamin D found in dairy products or in typical vitamin pills, must be chemically changed by the liver and kidney into calcitriol before it is biologically active. The body normally uses small amounts of calcitriol to regulate its blood calcium levels. However, for any possible therapeutic effect, MDS patients require much higher levels of calcitriol than the body can produce from dietary vitamin D. DN-101 provides MDS patients with high doses of calcitriol in a pill form.

Laboratory studies have demonstrated evidence supporting the use of calcitriol in MDS. High dose calcitriol slows the growth of leukemic cells (cancerous cells) and increases the growth of normal bone marrow cells. Some patients with MDS may have low levels of calcitriol in their bone marrow.

Clinical study results in patients with MDS have been mixed- some positive and some negative results. Elevated calcium in the blood occurred frequently and prevented the use of higher, more potentially therapeutic doses.

Novacea tested a new formulation of calcitriol, DN-101, in a Phase 1 study. In that study the maximum tolerated dose of DN-101 that did not cause high blood calcium levels when given weekly for several months was determined. That dose is within the range that is potentially therapeutic for MDS patients and will be used in this MDS study.

The purposes of this study are to determine if HDPA DN-101 treatment:

* increases the number of red blood cells, white blood cells, and platelets in the blood
* reduces the number of blood transfusions
* reduces the number of serious infections requiring antibiotics
* reduces the number of serious bleeding events
* improves fatigue

Conditions

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Myelodysplastic Syndrome

Keywords

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myelodysplastic syndrome MDS

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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DN-101 (calcitriol)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of low or intermediate-1 risk MDS
* Dependent on monthly blood transfusions
* No cancer within the last 5 years (cured skin cancer is allowed)
* No heart attack or stroke within the last 6 months
* No kidney stones within the last 5 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novacea

INDUSTRY

Sponsor Role lead

Locations

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Clinical Research Consultants, Inc.

Hoover, Alabama, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

James A. Haley Veterans Hospital

Tampa, Florida, United States

Site Status

Rush Cancer Institute MDS Center

Chicago, Illinois, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

The Cleveland Clinic Foundation, Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Boston Baskin Cancer Group

Memphis, Tennessee, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Mellibovsky L, Diez A, Perez-Vila E, Serrano S, Nacher M, Aubia J, Supervia A, Recker RR. Vitamin D treatment in myelodysplastic syndromes. Br J Haematol. 1998 Mar;100(3):516-20. doi: 10.1046/j.1365-2141.1998.00598.x.

Reference Type BACKGROUND
PMID: 9504634 (View on PubMed)

Beer TM, Munar M, Henner WD. A Phase I trial of pulse calcitriol in patients with refractory malignancies: pulse dosing permits substantial dose escalation. Cancer. 2001 Jun 15;91(12):2431-9.

Reference Type BACKGROUND
PMID: 11413535 (View on PubMed)

Beer TM, Eilers KM, Garzotto M, Egorin MJ, Lowe BA, Henner WD. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol. 2003 Jan 1;21(1):123-8. doi: 10.1200/jco.2003.05.117.

Reference Type BACKGROUND
PMID: 12506180 (View on PubMed)

Other Identifiers

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DN101-003

Identifier Type: -

Identifier Source: org_study_id