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Sponsors and Collaborators: |
Children's Hospital Medical Center, Cincinnati Novartis |
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Information provided by: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00411619 |
The purpose of the study is to evaluate the safety and potential side effects of everolimus (an experimental drug) on a person with Tuberous Sclerosis Complex who also has been diagnosed with a brain tumor (astrocytoma)
The hypothesis is that the drug will cause the tumor size to decrease, and may have beneficial activity separate from effects on tumors in patients.
Condition | Intervention | Phase |
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Tuberous Sclerosis Subependymal Giant Cell Astrocytoma |
Drug: Everolimus |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Everolimus (RAD001)Therapy of Giant Cell Astrocytomas in Patients With Tuberous Sclerosis Complex |
Estimated Enrollment: | 25 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Tuberous Sclerosis Complex (TSC)is a genetic disorder with a birth incidence of approximately one in six thousand. Five to twenty percent of patients with TSC will develop astrocytoma, a slowly progressive tumor. They grow and cause damage to surrounding brain tissue, blockage of spinal fluid (hydrocephalus), blindness, trouble walking, seizures, and brain damage. If untreated, they can be fatal. Standard treatment involves surgery to remove the tumor; however surgery may itself cause brain damage, bleeding, or infection, as well as other complications. Studies have shown that everolimus suppresses the chemicals that cause tumors to grow in tuberous sclerosis, and may cause them to shrink.
The primary objective of this study is to find out the effects of everolimus on astrocytomas in a six month trial in patients with Tuberous Sclerosis who have been diagnosed with an astrocytoma
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | David N Franz, M.D. | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Cincinnati Children's Hospital Medical Center ( Dr. David Franz ) |
Study ID Numbers: | CCHMC IRB# 06-07-50 |
Study First Received: | December 12, 2006 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00411619 |
Health Authority: | United States: Food and Drug Administration |
Tuberous Sclerosis Complex (TSC) Subendymal Giant Cell Astrocytomas (SEGA'S) Mammalian Target of Rapamycin (mTOR) Everolimus (RAD001) Tuberous Sclerosis with Subependymal Giant Cell Astrocytomas |
Everolimus Sirolimus Astrocytoma Nervous System Malformations Sclerosis Neurodegenerative Diseases Bourneville syndrome Neuroectodermal Tumors Tuberous Sclerosis Heredodegenerative Disorders, Nervous System |
Genetic Diseases, Inborn Tuberous sclerosis Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Malformations of Cortical Development Congenital Abnormalities Neoplasms, Glandular and Epithelial Neurocutaneous Syndromes |
Neoplasms Pathologic Processes Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Nervous System Diseases |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Immunosuppressive Agents Hamartoma Pharmacologic Actions |