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

This study has been terminated.

( terminated due to lack of accrual. )

First Received: September 22, 2005 Last Updated: April 18, 2007 History of Changes

Sponsor:	Oncology Specialties, Alabama
Information provided by:	Oncology Specialties, Alabama
ClinicalTrials.gov Identifier:	NCT00225992

Purpose

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	Intervention	Phase
Myelodysplastic Syndrome (MDS)	Drug: Arsenic Trioxide	Phase II

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:

MedlinePlus related topics: Arsenic

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225992

Locations

United States, Alabama
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Comprehensive Cancer Institute
Decatur, Alabama, United States, 358601

Sponsors and Collaborators

Oncology Specialties, Alabama

Investigators

Principal Investigator:

John M. Waples, MD

Oncology Specialties, PC

More Information

Additional Information:

Comprehensive Cancer Institute This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CCI-MDS-04
Study First Received:	September 22, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00225992 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Disease
Precancerous Conditions
Hematologic Diseases
Antineoplastic Agents
Myelodysplastic Syndromes
Arsenic trioxide
Pharmacologic Actions

Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 09, 2009