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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Collaborative Ependymoma Research Network |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00883688 |
Primary Objective:
To estimate the sustained objective response rates (complete response - CR plus partial response - PR) to lapatinib 900 mg/m2/dose bid, bevacizumab 10 mg/kg iv q 2 weeks in children with recurrent or refractory ependymoma.
Secondary Objectives:
Condition | Intervention | Phase |
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Brain Cancer Pediatric Cancers |
Drug: Bevacizumab Drug: Lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma |
Estimated Enrollment: | 40 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Bevacizumab + Lapatinib: Experimental |
Drug: Bevacizumab
10 mg/kg given by vein over 90 minutes for first injection (30-60 minutes for subsequent doses) every 2 weeks while on study (2 times during each 4-week "study cycle").
Drug: Lapatinib
Pills of 900 mg/m^2/dose given orally 2 times each day.
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Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must not have received: CYP3A4 inhibitors within seven (7) days prior to registration on protocol and for the duration of the study.
However, amiodarone, another CYP3A4 inhibitor, should have been discontinued 6 months prior to registration and for the duration of the study.
Must have the following tests as defined by the following within 7 days prior to registration and again within 7 days prior to the start of therapy: Bone marrow: Absolute neutrophil count of > / = 1000/microliter, Platelets > / = 100,000/microliter (transfusion independent), Hemoglobin > or = 8.0 g/dL (transfusion independent); Renal: Serum creatinine < / = 1.5 times upper limit of institutional normal for age or GFR
Exclusion Criteria:
Contact: Michael E. Rytting, MD | 713-792-6620 |
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Michael E. Rytting, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Michael E. Rytting, MD / Professor ) |
Study ID Numbers: | CERN08-01 |
Study First Received: | April 17, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00883688 History of Changes |
Health Authority: | United States: Institutional Review Board |
Brain Tumor Recurrent Ependymoma Refractory Ependymoma Intracranial ependymoma Ependymoblastoma Subependymoma Myxopapillary Clear cell |
Anaplastic Bevacizumab Avastin Anti-VEGF Monoclonal Antibody rhuMAb-VEGF Lapatinib Tykerb GW572016 |
Immunologic Factors Central Nervous System Diseases Lapatinib Central Nervous System Neoplasms Bevacizumab Brain Diseases Protein Kinase Inhibitors Angiogenesis Inhibitors Ependymoma Recurrence |
Antibodies, Monoclonal Brain Neoplasms Neuroectodermal Tumors Antibodies Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Nervous System Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Bevacizumab Brain Diseases Protein Kinase Inhibitors Ependymoma Antibodies, Monoclonal Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Growth Inhibitors |
Glioma Angiogenesis Modulating Agents Nervous System Neoplasms Neoplasms by Histologic Type Growth Substances Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Lapatinib Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Brain Neoplasms Neoplasms Neoplasms, Neuroepithelial |