Myelodysplastic SyndromePhase 1/2NCT00195104
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
A Phase 1/2 study testing Arsenic Trioxide (Tricenox) and Cytarabine in people with Myelodysplastic Syndrome, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Arsenic Trioxide (Tricenox) and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2003to 20 Jun 2006
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of high-risk MDS (IPSS int-2).
- No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).
Who cannot join
- Pregnant or lactating women.
- Absolute QT interval >460 msec in the presence of serum potassium and magnesium values within the normal range.
- Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
- Uncontrolled or severe cardiovascular or pulmonary disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medcial College of Cornell University
New York, New York, 10021
About this study
Official title: Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-risk Myelodysplastic Syndrome and Poor-prognosis Acute Myelogenous Leukemia
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
Read the detailed description
This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.
Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Arsenic Trioxide (Tricenox), Cytarabine
- Keywords
- Myelodysplastic Syndrome
- 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 Trioxide (Tricenox)Drug
CytarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | Arsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 1 to 4 hours Receives: Drug: Arsenic Trioxide (Tricenox); Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML.
Measured: 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML
To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.
Measured: 4 weeks after the last study treatment
Secondary outcomes (1)
To determine the CR and PR rates in patients with high-risk MDS and poor-prognosis AML treated with the combination of ATO and low-dose ara-C.
Measured: 4 weeks after the last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study start17 Sep 2003
- Primary completion17 Mar 2006
- Study completion20 Jun 2006
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.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gail Roboz, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195104
- Sponsor's protocol ID
- 0603-887
- Status last verified
- Mar 2017
- First submitted
- 14 Sep 2005
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-risk Myelodysplastic Syndrome and Poor-prognosis Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00195104
- Acronym / sponsor ID
- 0603-887
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 17 Sep 2003 (actual)
- Primary completion
- 17 Mar 2006 (actual)
- Study completion
- 20 Jun 2006 (actual)
- First posted
- 19 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.
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
Detailed description
This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.
Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: Arsenic Trioxide (Tricenox), Drug: CytarabineArsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 1 to 4 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologic diagnosis of high-risk MDS (IPSS int-2).
- No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Absolute QT interval >460 msec in the presence of serum potassium and magnesium values within the normal range.
- Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
- Uncontrolled or severe cardiovascular or pulmonary disease.
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 (Tricenox) | Drug | All Patients |
| Cytarabine | Drug | All Patients |
Primary outcome
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML.
Time frame: 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML
To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.
Time frame: 4 weeks after the last study treatment
1 secondary outcome
To determine the CR and PR rates in patients with high-risk MDS and poor-prognosis AML treated with the combination of ATO and low-dose ara-C.
Time frame: 4 weeks after the last study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Related InfoLink 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.
Gail Roboz, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arsenic Trioxide (Tricenox) and Cytarabine in people with Myelodysplastic Syndrome, run by Weill Medical College of Cornell University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML. (time frame: 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML). 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 3 Mar 2017.