Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
Phase 1
Completed
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Registration Number
- NCT00195104
- Lead Sponsor
- Weill Medical College of Cornell University
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Patients Arsenic Trioxide (Tricenox) Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 1 to 4 hours All Patients Cytarabine Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 1 to 4 hours
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Weill Medcial College of Cornell University
🇺🇸New York, New York, United States