Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Information source: Oncology Specialties, Alabama
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelodysplastic Syndrome (MDS)
Intervention: Arsenic Trioxide (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Oncology Specialties, Alabama Official(s) and/or principal investigator(s):
John M. Waples, MD, Principal Investigator, Affiliation: Oncology Specialties, PC
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.
Clinical Details
Official title: A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Study design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): 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.
Locations and Contacts
Comprehensive Cancer Institute, Huntsville, Alabama 35801, United States
Comprehensive Cancer Institute, Huntsville, Alabama 35801, United States
Comprehensive Cancer Institute, Decatur, Alabama 358601, United States
Additional Information
Comprehensive Cancer Institute
Last updated: April 18, 2007
|
