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

Primary Purpose

Myelodysplastic Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Arsenic Trioxide (Tricenox)
Cytarabine
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Medcial College of Cornell University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Patients

Arm Description

Arsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 1 to 4 hours

Outcomes

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.

Full Information

First Posted
September 14, 2005
Last Updated
March 2, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00195104
Brief Title
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 17, 2003 (Actual)
Primary Completion Date
March 17, 2006 (Actual)
Study Completion Date
June 20, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Patients
Arm Type
Experimental
Arm Description
Arsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 1 to 4 hours
Intervention Type
Drug
Intervention Name(s)
Arsenic Trioxide (Tricenox)
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Roboz, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medcial College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/20956016
Description
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Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

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