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MLN8237 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia

2014-08-27 03:12:30 | BioPortfolio

Summary

RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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.

Description

OBJECTIVES:

Primary

- 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).

Secondary

- 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Childhood Germ Cell Tumor

Intervention

Aurora A kinase inhibitor MLN8237, laboratory biomarker analysis, pharmacological study

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:30-0400

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Medical and Biotech [MESH] Definitions

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.

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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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