Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
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
1 other identifier
interventional
87
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2003
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2006
CompletedMarch 3, 2017
March 1, 2017
2.5 years
September 14, 2005
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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.
4 weeks after the last study treatment
Study Arms (1)
All Patients
EXPERIMENTALArsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 1 to 4 hours
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Medcial College of Cornell University
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Roboz, M.D.
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 19, 2005
Study Start
September 17, 2003
Primary Completion
March 17, 2006
Study Completion
June 20, 2006
Last Updated
March 3, 2017
Record last verified: 2017-03