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

Sponsor

Oncology Specialties, Alabama (Other)

Overall Status

Terminated

CT.gov ID

NCT00225992

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome (MDS)	Drug: Arsenic Trioxide	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Institute	Decatur	Alabama	United States	358601
2	Comprehensive Cancer Institute	Huntsville	Alabama	United States	35801

Sponsors and Collaborators

Oncology Specialties, Alabama

Investigators

Principal Investigator: John M. Waples, MD, Oncology Specialties, PC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Comprehensive Cancer Institute

Publications

None provided.

Responsible Party:

Oncology Specialties, Alabama

ClinicalTrials.gov Identifier:

NCT00225992

Other Study ID Numbers:

CCI-MDS-04

First Posted:

Sep 26, 2005

Last Update Posted:

Oct 11, 2012

Last Verified:

Oct 1, 2012

Additional relevant MeSH terms:

Preleukemia

Myelodysplastic Syndromes

Syndrome

Arsenic Trioxide

Study Results

No Results Posted as of Oct 11, 2012