Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
NCT ID: NCT00225992
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
INTERVENTIONAL
2004-02-29
2007-11-30
Brief Summary
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Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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Arsenic Trioxide
Eligibility Criteria
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Inclusion Criteria
* Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment
* ECOG performance status of 0-2
* An EKG must be performed within 7 days prior to treatment to confirm QT interval \<460msec.
* Serum creatinine less than or equal to 2.5 times the upper limit of normal.
* Serum bilirubin less than or equal to 2.5 times the upper limit of normal.
* Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
* Patients must be 18 years of age to participate in this study
Exclusion Criteria
* Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range.
* Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays.
* Peripheral neuropathy greater than or equal to 2.
* Evidence of active infection
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.
18 Years
85 Years
ALL
No
Sponsors
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Oncology Specialties, Alabama
OTHER
Responsible Party
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Principal Investigators
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John M. Waples, MD
Role: PRINCIPAL_INVESTIGATOR
Oncology Specialties, PC
Locations
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Comprehensive Cancer Institute
Decatur, Alabama, United States
Comprehensive Cancer Institute
Huntsville, Alabama, United States
Countries
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Related Links
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Comprehensive Cancer Institute
Other Identifiers
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CCI-MDS-04
Identifier Type: -
Identifier Source: org_study_id