Phase II Research Study of Arsenic Trioxide (Trisenox) in... | NCT00225992

Studies
Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

NCT00225992

Sponsor

Oncology Specialties, Alabama

Status

Terminated

Last Update Posted

Oct 11, 2012Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

Arsenic Trioxide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

terminated due to lack of accrual.

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Sep 22, 2005

First Submission Date that Met QC Criteria

Sep 23, 2005

First Posted Date

Sep 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2012

Last Update Posted Date

Oct 11, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule.

Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Arsenic Trioxide	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation
Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment
ECOG performance status of 0-2
An EKG must be performed within 7 days prior to treatment to confirm QT interval <460msec.
Serum creatinine less than or equal to 2.5 times the upper limit of normal.
Serum bilirubin less than or equal to 2.5 times the upper limit of normal.
Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
Patients must be 18 years of age to participate in this study

Exclusion Criteria:

Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception.
Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range.
Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays.
Peripheral neuropathy greater than or equal to 2.
Evidence of active infection
Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Cancer Institute		Decatur	Alabama	358601	United States
Comprehensive Cancer Institute

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D001152	Arsenicals
D007287	Inorganic Chemicals
D010087	Oxides
D017601	Oxygen Compounds