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

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00195104

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 I Phase II

MedlinePlus related topics: Arsenic Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Cytarabine Arsenic trioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy 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

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	0603-887
Study First Received:	September 14, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00195104 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:

Myelodysplastic Syndrome

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Arsenic trioxide
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Immunosuppressive Agents
Antiviral Agents
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Bone Marrow Diseases
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Syndrome

Therapeutic Uses
Cytarabine
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Arsenic trioxide
Leukemia, Myeloid
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 06, 2009