Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT00020969|
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : October 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: arsenic trioxide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes|
|Actual Study Start Date :||March 2001|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|