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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.)
Sponsor:
Information provided by (Responsible Party):
Oncology Specialties, Alabama
ClinicalTrials.gov Identifier:
NCT00225992
First received: September 22, 2005
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oncology Specialties, Alabama:

Study Start Date: February 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  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
Decatur, Alabama, United States, 358601
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Sponsors and Collaborators
Oncology Specialties, Alabama
Investigators
Principal Investigator: John M. Waples, MD Oncology Specialties, PC
  More Information

No publications provided

Responsible Party: Oncology Specialties, Alabama
ClinicalTrials.gov Identifier: NCT00225992     History of Changes
Other Study ID Numbers: CCI-MDS-04
Study First Received: September 22, 2005
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
 Neoplasms
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013