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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
CERN Foundation - Collaborative Ependymoma Research Network |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00883688 |
Purpose
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 |
|---|---|---|
|
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: | July 2009 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael E. Rytting, MD | 713-792-6620 |
| United States, California | |
| Stanford University Medical Center | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| Children's Memorial Hospital | Not yet recruiting |
| Chicago, Illinois, United States, 60614 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Not yet recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Not yet recruiting |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Michael E. Rytting, MD | |
| Principal Investigator: | Michael E. Rytting, MD | U.T. M.D. Anderson Cancer Center |
More Information
| 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: | July 24, 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 |
|
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 |