Myelodysplastic Syndrome Clinical Trial
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
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.
Full Description
OBJECTIVES:
Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide.
Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug.
Determine the durability of responses in patients treated with this drug.
Determine the duration of overall and progression-free survival of patients treated with this drug.
Assess the quality of life of patients treated with this drug.
Assess the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk).
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion.
Patients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this study.
Eligibility Criteria
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
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There are 8 Locations for this study
Tucson Arizona, 85724, United States
La Jolla California, 92037, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Boca Raton Florida, 33428, United States
Atlanta Georgia, 30342, United States
Corpus Christi Texas, 78412, United States
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