Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT01419496

First received: August 17, 2011

Last updated: October 4, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2011

Last Updated Date

October 4, 2011

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in Stat3 and Stat5 in paired diagnostic and relapsed AML samples [ Designated as safety issue: No ]
Reduction in chemotherapy sensitivity by relapsed samples compared to diagnostic samples [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01419496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Proteins in Promoting Chemotherapy Resistance in Samples From Patients With Acute Myeloid Leukemia

Official Title ^ICMJE

Identifying Stat3-Dependent Chemotherapy Resistance Pathways in Relapsed AML

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about cancer and development of drug resistance in patients.

PURPOSE: This research trial is studying proteins that may promote chemotherapy resistance in samples from patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

Investigate whether changes in prosurvival signaling occur by comparing activation of the signal transducer and activator of transcription-3 (Stat3) and Stat5 pathways in paired diagnostic and relapse samples.
Investigate changes in leukemia cell responses to extrinsic cues from the environment change, using a bone marrow stromal-cell co-culture model of chemotherapy resistance.

OUTLINE: Cryopreserved samples are analyzed for Stat3 and Stat5 expression by flow cytometry and in vitro chemotherapy sensitivity.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Genetic: protein expression analysis
Other: flow cytometry
Other: laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Paired diagnostic and relapsed cryopreserved samples from patients with acute myeloid leukemia

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Both

Ages

up to 30 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01419496

Other Study ID Numbers ^ICMJE

CDR0000709080, COG-AAML12B1

Has Data Monitoring Committee

Not Provided

Responsible Party

Peter C. Adamson, Children's Oncology Group - Group Chair Office

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Michele S. Redell, MD, PhD

Texas Children's Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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