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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00057031
Other study ID # DN101-003
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received March 26, 2003
Last updated October 31, 2006
Start date November 2002
Est. completion date March 2004

Study information

Verified date February 2005
Source Novacea
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 46
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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

Study Design

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


Intervention

Drug:
DN-101 (calcitriol)


Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York
United States Rush Cancer Institute MDS Center Chicago Illinois
United States The Cleveland Clinic Foundation, Taussig Cancer Center Cleveland Ohio
United States Clinical Research Consultants, Inc. Hoover Alabama
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Boston Baskin Cancer Group Memphis Tennessee
United States Oregon Health Sciences University Portland Oregon
United States University of California, San Francisco San Francisco California
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States James A. Haley Veterans Hospital Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Novacea

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Mellibovsky L, Díez A, Pérez-Vila E, Serrano S, Nacher M, Aubía J, Supervía A, Recker RR. Vitamin D treatment in myelodysplastic syndromes. Br J Haematol. 1998 Mar;100(3):516-20. — View Citation

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