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

Information source: Novacea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndrome

Intervention: DN-101 (calcitriol) (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Novacea

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.

Clinical Details

Official title: A Phase 2, Multicenter, Open Label Study of the Safety and Efficacy of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome

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

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Clinical Research Consultants, Inc., Hoover, Alabama 35216, United States

University of California, San Francisco, San Francisco, California 94143, United States

James A. Haley Veterans Hospital, Tampa, Florida 33612, United States

Rush Cancer Institute MDS Center, Chicago, Illinois 60612, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

The Cleveland Clinic Foundation, Taussig Cancer Center, Cleveland, Ohio 44195, United States

Oregon Health Sciences University, Portland, Oregon 97201, United States

Boston Baskin Cancer Group, Memphis, Tennessee 38104, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Additional Information

Related publications:

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.

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.

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.

Starting date: November 2002
Last updated: October 31, 2006

Page last updated: August 23, 2015

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