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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Arsenic trioxide
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014