Status:
TERMINATED
Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Oncology Specialties, Alabama
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts ...
Eligibility Criteria
Inclusion
- Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation
- 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
- Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception.
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00225992
Start Date
February 1 2004
End Date
November 1 2007
Last Update
October 11 2012
Active Locations (2)
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1
Comprehensive Cancer Institute
Decatur, Alabama, United States, 358601
2
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801