Arsenic Trioxide and Cholecalciferol (Vitamin D) in Treating Patients With Myelodysplastic Syndromes
NCT00104806 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2018-08-10
Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cholecalciferol (vitamin D) may help cancer cells become normal cells. Giving arsenic trioxide together with cholecalciferol (vitamin D) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with cholecalciferol (vitamin D) works in treating patients with myelodysplastic syndromes.
Conditions
- Leukemia
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
Interventions
- DIETARY_SUPPLEMENT
-
cholecalciferol
100 milligrams orally once a day for 28 days
- DRUG
-
arsenic trioxide
0.3 milligram/kilogram weight intravenously for 5 days (loading) then 0.25/kg weight intravenously biweekly
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Istvan Molnar, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2006-01-31
- Completion
- 2010-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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