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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

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
United States, Alabama | |
Comprehensive Cancer Institute | |
Decatur, Alabama, United States, 358601 | |
Comprehensive Cancer Institute | |
Huntsville, Alabama, United States, 35801 |
Principal Investigator: | John M. Waples, MD | Oncology Specialties, PC |
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 |
Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Neoplasms Arsenic Trioxide Antineoplastic Agents |