Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT01150656

First received: June 24, 2010

Last updated: February 4, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 24, 2010

Last Updated Date

February 4, 2011

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Obatoclax mesylate activity [ Designated as safety issue: No ]
Optimum in vitro combinations of obatoclax mesylate [ Designated as safety issue: No ]
Pharmacodynamic (PD) biomarkers of activity [ Designated as safety issue: No ]
Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML) [ Designated as safety issue: No ]
Disease progression in a xenograft model of MLL-rearranged infant AML [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01150656 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Physical assessment (in xenograft model) [ Designated as safety issue: No ]
Peripheral blast count reduction [ Designated as safety issue: No ]
Apoptosis and/or ATG induction [ Designated as safety issue: No ]
Modulation of relevant PD biomarkers [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia

Official Title ^ICMJE

SCOR in Targeted Therapies for Infant Leukemias Project 2: Targeting Apoptosis in Leukemia in Infants

Brief Summary

RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate on cancer cells. It may also help doctors identify biomarkers related to cancer.

PURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

Determine comprehensive gene and protein expression profiles of in vitro sensitivity and resistance to obatoclax mesylate in multiple-lineage leukemia (MLL)-rearranged cell lines and primary infant acute myeloid leukemia (AML) samples.
Define optimum in vitro combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs in MLL-rearranged leukemia cell lines and primary infant AML samples.
Identify synergistic combinations based on a pharmacodynamic modeling and simulation construct.
Determine whether combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs improves survival in a xenograft model of MLL-rearranged infant AML.

OUTLINE: This is a multicenter study.

Obatoclax mesylate activity is assessed via the MTT assay. A priori features of acute myeloid leukemia (AML) blasts relating to the apoptosis and ATG cell death pathways and their execution are characterized using microarray analysis and quantitative real-time (Q-RT) PCR. Gene and protein expression is described and quantified using Q-RT PCR and western blot analysis at specific time points after obatoclax mesylate exposure to identify pharmacodynamic biomarkers of activity and characterize the cell death mechanism in multiple-lineage leukemia (MLL)+ AML. The MTT assay is performed using obatoclax mesylate-cytotoxic chemotherapy combinations to determine synergy focusing on common cytotoxic drugs employed in AML treatment regimens.

Obatoclax mesylate efficacy is tested in a therapeutic NOG xenograft model of primary MLL+ infant AML.

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: gene expression analysis
Genetic: microarray analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: western blotting
Other: laboratory biomarker analysis
Other: pharmacological study

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

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of acute myeloid leukemia (AML)
Cryopreserved samples from infants with AML available

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Both

Ages

up to 2 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

NCT01150656

Other Study ID Numbers ^ICMJE

CDR0000675718, COG-AAML10B17

Has Data Monitoring Committee

Not Provided

Responsible Party

Gregory H. Reaman, Children's Oncology Group - Group Chair Office

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Carolyn A. Felix, MD

Children's Hospital of Philadelphia

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2011

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

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