Myelodysplastic Syndrome (MDS)
Conditions
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 (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule. 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.
Interventions
DRUGArsenic Trioxide
Sponsors
Oncology Specialties, Alabama
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
* 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 criteria
* 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.
Countries
United States
Outcome results
None listed