Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): sponsor discontinues support
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Complete response rate
- timeFrame
- 6 months
- measure
- toxicity assessment after therapy
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available