Myelodysplastic Syndrome (MDS)Phase 2NCT00225992
Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Arsenic Trioxide in people with Myelodysplastic Syndrome (MDS), run by Oncology Specialties, Alabama at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- Arsenic Trioxide
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Feb 2004to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Comprehensive Cancer Institute
Decatur, Alabama, 358601
Comprehensive Cancer Institute
Huntsville, Alabama, 35801
About this study
Official title: A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
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.
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- Arsenic Trioxide
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: terminated due to lack of accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Oncology Specialties, Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M. Waples, MD, Principal investigator, Oncology Specialties, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225992
- Sponsor's protocol ID
- CCI-MDS-04
- Status last verified
- Oct 2012
- First submitted
- 22 Sep 2005
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00225992
- Acronym / sponsor ID
- CCI-MDS-04
- Conditions
- Myelodysplastic Syndrome (MDS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to lack of accrual.
- Lead sponsor
- Oncology Specialties, AlabamaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arsenic Trioxide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: terminated due to lack of accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
- Comprehensive Cancer InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Waples, MD principal investigator
Oncology Specialties, PC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arsenic Trioxide in people with Myelodysplastic Syndrome (MDS), run by Oncology Specialties, Alabama at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated due to lack of accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.