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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:
Oncology Specialties, Alabama
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
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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: None (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:
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| 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 Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00225992
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
| 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 |
Additional relevant MeSH terms:
|
Syndrome Myelodysplastic Syndromes Preleukemia Disease Pathologic Processes Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Neoplasms Arsenic trioxide Antineoplastic Agents |
ClinicalTrials.gov processed this record on August 17, 2017