Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2

Details

• Lead Sponsor: Oncology Specialties, Alabama
• Treatments: Arsenic Trioxide

Criteria

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.