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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00739427 |
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 MLN8237 and to see how well it works in treating young patients with relapsed or refractory solid tumors or acute lymphoblastic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Neuroblastoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: Aurora A kinase inhibitor MLN8237 Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: immunohistochemistry staining method Other: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of MLN8237, an Oral Selective Small Molecule Inhibitor of Aurora A Kinase, in Pediatric Patients With Relapsed/Refractory Solid Tumors and Leukemia |
Estimated Enrollment: | 102 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter phase I, dose escalation followed by a phase II study. Patients are stratified according to diagnosis (solid tumors vs neuroblastoma vs acute lymphoblastic leukemia).
Patients receive oral Aurora A kinase inhibitor MLN8237 once or twice daily on days 1-7. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Whole blood samples are collected from all patients for genotyping for polymorphisms in UGT1A1 enzymes and polymorphisms in the Aurora A kinase gene. For patients in the phase II portion of the study, previously preserved tumor tissue blocks and bone marrow or peripheral blasts are evaluated for Aurora A kinase protein using IHC, mRNA expression, and gene amplification using FISH or quantitative PCR. Blood samples are also collected periodically during the first course of therapy for pharmacokinetics studies.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor (phase I, stratum A), neuroblastoma (phase II, stratum B), or relapsed/refractory acute lymphoblastic leukemia (ALL) (phase II, stratum C)
Relapsed or refractory disease
Meets the following criteria for measurable or evaluable disease as defined below by stratum:
Stratum B: meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Patients with solid tumors (phase I, stratum A) must meet the following hematopoietic criteria:
Patients in phase II portion of the study (stratum B & C) must meet the following hematopoietic criteria:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70ml/min OR serum creatinine based on age/gender (male [M], female [F]) as follows (in mg/dL):
PRIOR CONCURRENT THERAPY:
Concurrent corticosteroids allowed provided patient is on a stable or decreasing dose of corticosteroid for
No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biological therapy
United States, Alabama | |
UAB Comprehensive Cancer Center | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
United States, California | |
Children's Hospital of Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Violet Shen 714-532-8636 | |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, District of Columbia, United States, 20010-2970 | |
Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 |
Study Chair: | Yael P. Mosse, MD | Children's Hospital of Philadelphia |
Responsible Party: | Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital ( Susan M. Blaney ) |
Study ID Numbers: | CDR0000610257, COG-ADVL0812 |
Study First Received: | August 20, 2008 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00739427 History of Changes |
Health Authority: | Unspecified |
unspecified childhood solid tumor, protocol specific recurrent neuroblastoma recurrent childhood acute lymphoblastic leukemia |
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Neuroectodermal Tumors, Primitive Neuroblastoma Recurrence Leukemia Lymphatic Diseases |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Neuroectodermal Tumors, Primitive Immune System Diseases Neoplasms, Nerve Tissue Neuroblastoma Neuroectodermal Tumors |
Leukemia Lymphatic Diseases Neoplasms Neoplasms, Germ Cell and Embryonal Lymphoproliferative Disorders Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |