Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes (NCT00020969) | Clinical Trial Compass
TerminatedPhase 2
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
United StatesStarted 2001-03
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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