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

NCT ID: NCT00225992

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-11-30

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.

Conditions

Myelodysplastic Syndrome (MDS)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Arsenic Trioxide

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncology Specialties, Alabama

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M. Waples, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Specialties, PC

Locations

Comprehensive Cancer Institute

Decatur, Alabama, United States

Comprehensive Cancer Institute

Huntsville, Alabama, United States

Countries

United States

Related Links

http://www.ccihsv.com

Comprehensive Cancer Institute

Other Identifiers

CCI-MDS-04

Identifier Type: -

Identifier Source: org_study_id