Arsenic Trioxide in Combination With Cytarabine in Patients With High-Risk MDS and Poor-Prognosis AML

This study has been completed.
Information provided by:
Weill Medical College of Cornell University Identifier:
First received: September 14, 2005
Last updated: October 2, 2007
Last verified: October 2007
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.

Condition Intervention Phase
Myelodysplastic Syndrome
Drug: Arsenic Trioxide (Tricenox)
Drug: Cytarabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.
  • To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: July 2003
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00195104

United States, New York
Weill Medcial College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Gail Roboz, M.D. Weill Medical College of Cornell University
  More Information Identifier: NCT00195104     History of Changes
Other Study ID Numbers: 0603-887 
Study First Received: September 14, 2005
Last Updated: October 2, 2007

Keywords provided by Weill Medical College of Cornell University:
Myelodysplastic Syndrome

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Arsenic trioxide
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on January 19, 2017