NCT00225992

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2004

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

September 22, 2005

Last Update Submit

October 10, 2012

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

Arsenic TrioxideDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Comprehensive Cancer Institute

Decatur, Alabama, 358601, United States

Location

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • John M. Waples, MD

    Oncology Specialties, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

February 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

US(2)