Myelodysplastic SyndromePhase 2NCT00251511
A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
A Phase 2 study testing Arsenic Trioxide in people with Myelodysplastic Syndrome, run by Veeda Oncology at 1 site in United States.
Trial summary
This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS). Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Arsenic Trioxide
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to May 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, patients must fulfill all of the following criteria:
- Patients must have signed an IRB-approved informed consent.
- Patients with low, intermediate-1, intermediate-2, and high-risk MDS (defined by IPSS) with documented diagnosis of MDS (refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia with mixed lineage dysplasia, or chronic myelomonocytic leukemia).
- Patients must have a documented history of all transfusions (pRBC and/or platelets) received in the 60-day period prior to their initial Trisenox treatment on this protocol.
- Patients with ECOG Performance Status of 0 or 1 (see Appendix I).
- Absolute QT interval below 460 msec in the presence of serum potassium and magnesium values within the normal range.
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- Patients must be >/= 18 years of age.
- Patients must either be not of child bearing potential or have a negative serum pregnancy test within 24 hours prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 24 months.
- For patients of childbearing potential, patient has agreed to use 2 reliable forms of contraception simultaneously for at least 1 month before beginning Thalomid therapy, during Thalomid therapy, and for 1 month following discontinuation of Thalomid therapy.
- Renal function: creatinine < 1.5 x institutional upper limit of normal (ULN), CTCAE Grade 1.
- Hepatic function: bilirubin </= 1.5 x ULN, CTCAE Grade 1. AST </= 2.5 x ULN, CTCAE Grade 1.
- Serum potassium >4.0mEq/dL and serum magnesium >1.8 mg/dL.
Who cannot join
- Any of the following criteria will make the patient ineligible to participate in this study:
- Patients who have received prior chemotherapy or prior therapy with either Trisenox or Thalomid.
- Patients who have a history of hypersensitivity to arsenic or thalidomide or any of the components in these drugs.
- Patients with a significant history of cardiac disease (i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction in the last 6 months).
- Patients with a history of torsade de pointes.
- Patients planning to receive any concurrent therapy to treat MDS during the study treatment period.
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- Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- Patients with a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of these study drugs for MDS.
- Any patient who is pregnant or lactating.
- Any patient who is unable to comply with requirements of study.
- Patients with peripheral neuropathy >grade 1.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS).
Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Patients will be treated for a minimum of 12 weeks even in the absence of response. Following 12 weeks of treatment, patients will continue to receive study treatment until disease progression or unacceptable toxicity.
- Conditions
- Myelodysplastic Syndrome
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Study Endpoint:
Determine the response rate (by IWG criteria) of patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS) to biweekly Trisenox plus daily Thalomid
Secondary outcomes (2)
Secondary Study Endpoint(s):
Determine the toxicities associated with a biweekly Trisenox plus daily Thalomid regimen, the event-free survival, and the overall survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startAug 2004
- Primary completionJan 2006
- Study completionMay 2007
Why it stopped: Sponsor terminated trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veeda Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Ralph Boccia, MD, Principal investigator, Veeda Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251511
- Sponsor's protocol ID
- I-04-001
- Status last verified
- May 2012
- First submitted
- 8 Nov 2005
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00251511
- Acronym / sponsor ID
- I-04-001
- Conditions
- Myelodysplastic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated trial
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Veeda OncologyUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 10 Nov 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.
This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS).
Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Patients will be treated for a minimum of 12 weeks even in the absence of response. Following 12 weeks of treatment, patients will continue to receive study treatment until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be eligible for the study, patients must fulfill all of the following criteria:
Key exclusion criteria (11 listed)
- Any of the following criteria will make the patient ineligible to participate in this study:
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
Primary Study Endpoint:
Determine the response rate (by IWG criteria) of patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS) to biweekly Trisenox plus daily Thalomid
2 secondary outcomes
Secondary Study Endpoint(s):
Determine the toxicities associated with a biweekly Trisenox plus daily Thalomid regimen, the event-free survival, and the overall survival.
Results and safety
The study was stopped early (reason given: Sponsor terminated trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
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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.
Ralph Boccia, MD principal investigator
Veeda Oncology
1 site 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, run by Veeda Oncology at 1 site 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 12 inclusion and 11 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 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Sponsor terminated trial). 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.
What does the primary outcome measure?
Primary Study Endpoint:. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 May 2012.