Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
This trial is active, not recruiting.
|Conditions||leukemia, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2001|
|Trial identifier||NCT00020969, CDR0000068734, CTI-1058, NCI-G01-1971, UCLA-HSPC-010104701|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Tucson, AZ||Arizona Cancer Center at University of Arizona Health Sciences Center||no longer recruiting|
|La Jolla, CA||Green Cancer Center at Scripps Clinic||no longer recruiting|
|Los Angeles, CA||Jonsson Comprehensive Cancer Center, UCLA||no longer recruiting|
|Los Angeles, CA||USC/Norris Comprehensive Cancer Center and Hospital||no longer recruiting|
|Orange, CA||St. Joseph Hospital Regional Cancer Center - Orange||no longer recruiting|
|Boca Raton, FL||Lynn Regional Cancer Center West||no longer recruiting|
|Atlanta, GA||Georgia Cancer Specialists - Northside Office||no longer recruiting|
|Corpus Christi, TX||Corpus Christi Cancer Center||no longer recruiting|
Male or female participants at least 18 years old.
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
|Official title||Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes|
|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.|
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