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Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195104
First Posted: September 19, 2005
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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. [ 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 ]

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. [ Time Frame: 4 weeks after the last study treatment ]

Enrollment: 87
Actual Study Start Date: September 17, 2003
Study Completion Date: June 20, 2006
Primary Completion Date: March 17, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All Patients
Arsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 1 to 4 hours
Drug: Arsenic Trioxide (Tricenox) Drug: Cytarabine

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).

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195104


Locations
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
Investigators
Principal Investigator: Gail Roboz, M.D. Weill Medical College of Cornell University
  More Information

Additional Information:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00195104     History of Changes
Other Study ID Numbers: 0603-887
First Submitted: September 14, 2005
First Posted: September 19, 2005
Last Update Posted: March 3, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Cytarabine
Arsenic trioxide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs