Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
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|ClinicalTrials.gov Identifier: NCT00179881|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 27, 2011
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.
This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
|Condition or disease||Intervention/treatment||Phase|
|Brain Stem Neoplasms, Primary Neoplasms, Brain Stem||Drug: Carboplatin Drug: Thalomid Procedure: External Beam Radiation Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
- To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
- To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
- To determine the toxicity of this drug regimen.
- To determine whether the multi-agent chemotherapy regimen of thalidomide and carboplatin, in patients with recurrent brain stem gliomas will extend their survival as compared to historical controls.
- To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179881
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85016|
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|United States, Minnesota|
|Children's Hospitals and Clinics|
|Minneapolis, Minnesota, United States, 55404|
|Children's Hospitals and Clinics|
|Saint Paul, Minnesota, United States, 55404|
|United States, Missouri|
|Washington University Medical Center|
|St. Louis, Missouri, United States, 63110|
|United States, Ohio|
|Children's Medical Center|
|Dayton, Ohio, United States, 45404|
|Principal Investigator:||Stewart Goldman, MD||Ann & Robert H Lurie Children's Hospital of Chicago|