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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225992
Recruitment Status : Terminated (terminated due to lack of accrual.)
First Posted : September 26, 2005
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Oncology Specialties, Alabama

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225992


Locations
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United States, Alabama
Comprehensive Cancer Institute
Decatur, Alabama, United States, 358601
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Sponsors and Collaborators
Oncology Specialties, Alabama
Investigators
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Principal Investigator: John M. Waples, MD Oncology Specialties, PC
More Information
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Additional Information:

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Responsible Party: Oncology Specialties, Alabama
ClinicalTrials.gov Identifier: NCT00225992    
Other Study ID Numbers: CCI-MDS-04
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms
Arsenic Trioxide
Antineoplastic Agents