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| ID | Type | Description | Link |
|---|---|---|---|
| COG-AAML10B17 | Other Identifier | Children's Oncology Group | |
| NCI-2011-02239 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AAML10B17 | Other Identifier | Children's Oncology Group |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | |||
| microarray analysis | Genetic | |||
| protein expression analysis | Genetic | |||
| reverse transcriptase-polymerase chain reaction | Genetic | |||
| western blotting | Genetic | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Obatoclax mesylate activity | ||
| Optimum in vitro combinations of obatoclax mesylate | ||
| Pharmacodynamic (PD) biomarkers of activity | ||
| Cell death mechanism in multiple-lineage leukemia (MLL) acute myeloid leukemia (AML) | ||
| Disease progression in a xenograft model of MLL-rearranged infant AML |
| Measure | Description | Time Frame |
|---|---|---|
| Physical assessment (in xenograft model) | ||
| Peripheral blast count reduction | ||
| Apoptosis and/or ATG induction |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients With Acute Myeloid Leukemia
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn A. Felix, MD | Children's Hospital of Philadelphia | Principal Investigator |
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| Modulation of relevant PD biomarkers |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D046228 | Microarray Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D015153 | Blotting, Western |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D046208 | Microchip Analytical Procedures |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D055664 | Electrochemical Techniques |
| D015151 | Immunoblotting |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D015336 | Molecular Probe Techniques |
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