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Treatment on this study combines two drugs: Thalomidâ„¢ (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 Thalomidâ„¢ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid â„¢ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | |||
| Thalomid | Drug | |||
| External Beam Radiation Therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stewart Goldman, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Memorial Hospital |
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| Chicago |
| Illinois |
| 60614 |
| United States |
| Children's Hospitals and Clinics | Minneapolis | Minnesota | 55404 | United States |
| Children's Hospitals and Clinics | Saint Paul | Minnesota | 55404 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Children's Medical Center | Dayton | Ohio | 45404 | United States |
| ID | Term |
|---|---|
| D020295 | Brain Stem Neoplasms |
| ID | Term |
|---|---|
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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