NCT00104806

Arsenic Trioxide and Cholecalciferol (Vitamin D) in Treating Patients With Myelodysplastic Syndromes

Phase II Trial of Arsenic Trioxide and Dose-Escalated Cholecalciferol in Myelodysplastic Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Determine the complete response rate and the rate of hematological improvement in patients with myelodysplastic syndromes treated with arsenic trioxide and cholecalciferol (vitamin D). Secondary * Determine the safety of this regimen in these patients. * Determine the time to progression to acute myeloid leukemia, defined as blast ≥ 20%, in patients treated with this regimen. * Determine overall survival and progression-free survival of patients treated with this regimen. * Determine the effect of this regimen on bone marrow and peripheral blood mononuclear cell apoptosis and p21 protein expression in these patients. OUTLINE: This is an open-label, nonrandomized study. Patients receive oral cholecalciferol (vitamin D)\* once daily on days 1-28. Patients also receive arsenic trioxide IV over 1-4 hours on days 1-5 (week 1) and then twice weekly for 3 weeks (weeks 2-4) for course 1 and twice weekly for 4 weeks for all subsequent courses. Courses repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. NOTE: \* Patients who do not achieve a complete hematologic response receive escalating doses of cholecalciferol (vitamin D) at 3, 6, and 9 months during therapy in the absence of disease progression and unacceptable toxicity. At the completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-11-01
• Primary completion: 2006-01-01
• Completion: 2010-05-01
• First posted: 2005-03-04
• Last updated: 2018-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study