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

Tracking Information

First Received Date ^ICMJE

September 22, 2005

Last Updated Date

April 18, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00225992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Myelodysplastic Syndrome (MDS)

Intervention ^ICMJE

Drug: Arsenic Trioxide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00225992

Responsible Party

Study ID Numbers ^ICMJE

CCI-MDS-04

Study Sponsor ^ICMJE

Oncology Specialties, Alabama

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John M. Waples, MD

Oncology Specialties, PC

Information Provided By

Oncology Specialties, Alabama

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP