Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
- Conditions
- LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms
- Registration Number
- NCT00020969
- Lead Sponsor
- CTI BioPharma
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Lynn Regional Cancer Center West
🇺🇸Boca Raton, Florida, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸Orange, California, United States
Corpus Christi Cancer Center
🇺🇸Corpus Christi, Texas, United States
Green Cancer Center at Scripps Clinic
🇺🇸La Jolla, California, United States
Georgia Cancer Specialists - Northside Office
🇺🇸Atlanta, Georgia, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States