Arsenic Trioxide and Cholecalciferol (Vitamin D) in Treating Patients With Myelodysplastic Syndromes
Information source: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
Intervention: cholecalciferol (Dietary Supplement); arsenic trioxide (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Comprehensive Cancer Center of Wake Forest University Official(s) and/or principal investigator(s): Istvan Molnar, MD, Study Chair, Affiliation: Comprehensive Cancer Center of Wake Forest University
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.
Clinical Details
Official title: Phase II Trial of Arsenic Trioxide and Dose-Escalated Cholecalciferol in Myelodysplastic Syndrome
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Complete response ratetoxicity assessment after therapy
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndromes (MDS)
- Bone marrow aspirate and biopsy with karyotyping performed within the past 12
weeks
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- ECOG 0-2
Life expectancy
- More than 6 months
Hematopoietic
- Ferritin ≥ 50 ng/mL
- Folate (serum and/or red blood cell) normal
Hepatic
- Not specified
Renal
- Creatinine < 2. 0 mg/dL
- No history of hypercalcemia
Cardiovascular
- Absolute QT interval ≤ 460 msec by EKG with normal potassium and magnesium levels
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 weeks after study
participation
- Serum vitamin B_12 normal
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior biologic therapy allowed
- More than 28 days since prior hematopoietic growth factors (e. g., filgrastim [G-CSF],
sargramostim [GM-CSF], or epoetin alfa) for MDS
- No concurrent hematopoietic growth factors (e. g., G-CSF, GM-CSF, or epoetin alfa)
- No concurrent interleukin-11
Chemotherapy
- Prior chemotherapy allowed
Endocrine therapy
- Not specified
Radiotherapy
- Prior radiotherapy allowed
Surgery
- Not specified
Other
- More than 28 days since prior therapy for MDS except supportive therapy
- No concurrent cholecalciferol (vitamin D) analog, including topical therapy
- No concurrent vitamins or supplements containing cholecalciferol (vitamin D)
- No other concurrent therapy for MDS
Locations and Contacts
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Additional Information
Starting date: November 2004
Last updated: July 12, 2012
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