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PURPOSE: This phase II trial is studying the side effects of and how well MLN8237 works in treating young patients with relapsed or refractory solid tumors or leukemia.
- To determine the objective response rate in pediatric patients with relapsed or refractory solid tumors or leukemia treated with aurora A kinase inhibitor MLN8237 (MLN8237).
- To define and describe the toxicities of this regimen in these patients.
- To characterize the pharmacokinetics of this regimen in these patients.
- To evaluate aurora A kinase expression in tissue samples obtained at diagnosis and at relapse.
- To explore the relationship between polymorphic variations in the UDP-UDPglucuronosyltransferase gene UGT1A1 and exposure to MLN8237.
- To assess two common polymorphic variants in the aurora A kinase gene (Phe31Ile and Val57Ile) associated with tumorigenesis.
OUTLINE: This is a multicenter study. Patients are stratified according to type of tumor (solid tumor and measurable disease vs neuroblastoma with MIBG-positive lesions vs neuroblastoma with bone marrow involvement vs AML vs ALL).
Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-7. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Plasma samples are collected from all patients at baseline and periodically during course 1 for pharmacokinetic and other studies.
After completion of study therapy, patients are followed up for 5 years.
Masking: Open Label, Primary Purpose: Treatment
Childhood Germ Cell Tumor
Aurora A kinase inhibitor MLN8237, laboratory biomarker analysis, pharmacological study
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:12:30-0400
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RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of...
To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14...
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The small GTPase RalA is a known mediator of anchorage-independent growth in cancers and differentially regulated by adhesion and Aurora Kinase A (AURKA). Inhibiting AURKA hence offers a means of spec...
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Assembly of the mitotic spindle is essential for proper chromosome segregation during mitosis. Maintenance of spindle poles requires precise regulation of kinesin- and dynein-generated forces, and imp...
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Aurora kinase C is a chromosomal passenger protein that interacts with aurora kinase B in the regulation of MITOSIS. It is found primarily in GERM CELLS in the TESTIS, and may mediate CHROMOSOME SEGREGATION during SPERMATOGENESIS.
An aurora kinase that localizes to the CENTROSOME during MITOSIS and is involved in centrosome regulation and formation of the MITOTIC SPINDLE. Aurora A overexpression in many malignant tumor types suggests that it may be directly involved in NEOPLASTIC CELL TRANSFORMATION.
An aurora kinase that is a component of the chromosomal passenger protein complex and is involved in the regulation of MITOSIS. It mediates proper CHROMOSOME SEGREGATION and contractile ring function during CYTOKINESIS.
A key regulator of CELL CYCLE progression. It partners with CYCLIN E to regulate entry into S PHASE and also interacts with CYCLIN A to phosphorylate RETINOBLASTOMA PROTEIN. Its activity is inhibited by CYCLIN-DEPENDENT KINASE INHIBITOR P27 and CYCLIN-DEPENDENT KINASE INHIBITOR P21.
An INK4 cyclin-dependent kinase inhibitor containing four ANKYRIN-LIKE REPEATS. INK4B is often inactivated by deletions, mutations, or hypermethylation in HEMATOLOGIC NEOPLASMS.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...