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

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Cholecalciferol

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