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

Myelodysplastic Syndrome (MDS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225992
• Other study ID #: CCI-MDS-04
• Status: Terminated
• Phase: Phase 2
• First received: September 22, 2005
• Last updated: October 10, 2012
• Start date: February 2004
• Est. completion date: November 2007

Study information

• Verified date: October 2012
• Source: Oncology Specialties, Alabama
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Arsenic Trioxide

Locations

Country	Name	City	State
United States	Comprehensive Cancer Institute	Decatur	Alabama
United States	Comprehensive Cancer Institute	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Oncology Specialties, Alabama

Country where clinical trial is conducted

United States,