Clinical trial · Interventional
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
NCT00020969CI-TRIAL-00047464terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of myelodysplastic syndromes (MDS) * Refractory anemia (RA) * RA with ringed sideroblasts * RA with excess blasts (RAEB) * RAEB in transformation * Chronic myelomonocytic leukemia * Low-risk MDS patients: * If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial * No prior acute myeloid leukemia PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * More than 3 months Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * SGPT and SGOT no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients) Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * At least 30 days since prior radiotherapy Surgery: * Not specified Other: * At least 30 days since prior cytotoxic agents * At least 30 days since prior investigational agents * No prior arsenic trioxide
References
Publications (1)
- RESULTSchiller GJ, Slack J, Hainsworth JD, Mason J, Saleh M, Rizzieri D, Douer D, List AF. Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol. 2006 Jun 1;24(16):2456-64. doi: 10.1200/JCO.2005.03.7903. Epub 2006 May 1. PMID 16651647