Status:
TERMINATED
Arsenic Trioxide and Cholecalciferol (Vitamin D) in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 120 years
Phase:
PHASE2
Brief 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. Cholecalcifer...
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 (vit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00104806
Start Date
November 1 2004
End Date
May 1 2010
Last Update
August 10 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096