Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
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.
Drug: arsenic trioxide
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes|
|Study Start Date:||March 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020969
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Green Cancer Center at Scripps Clinic|
|La Jolla, California, United States, 92037-1027|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1678|
|St. Joseph Hospital Regional Cancer Center - Orange|
|Orange, California, United States, 92868-3849|
|United States, Florida|
|Lynn Regional Cancer Center West|
|Boca Raton, Florida, United States, 33428|
|United States, Georgia|
|Georgia Cancer Specialists - Northside Office|
|Atlanta, Georgia, United States, 30342|
|United States, Texas|
|Corpus Christi Cancer Center|
|Corpus Christi, Texas, United States, 78412|
|Study Chair:||Scott C. Stromatt, MD||CTI BioPharma|