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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-58 | Other Identifier | CCRRC | |
| JT 1208 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Sorafenibâ„¢ has the potential to inhibit tumor growth, tumor angiogenesis , and enhance radiation response. This study will test the combination of Sorafenibâ„¢ and radiation therapy with or without temozolomide to determine tolerance of the combined treatments. Defining safe dosing of Sorafenibâ„¢ in this combination therapy will be achieved.
The current standard of care for patients with brain metastatic malignancies is to receive radiation therapy alone, while the standard of care for patients with high grade primary brain malignancies, astrocytomas, is to receive to receive concurrent temozolomide with radiation therapy. In this phase I study, based on the range of efficacy of kinase inhibitors and its ability to cross the blood-brain barrier we will conduct two parallel studies. The first is to combine sorafenib and radiation therapy for the treatment of patients with brain metastases and the second is to combine sorafenib with temozolomide for primary brain tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Brain Metastasis | Experimental | Sorafenib and Radiotherapy |
|
| Cohort 2 - Gliomas | Experimental | Sorafenib and Radiotherapy, plus Temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Sorafenib 200mg twice daily during XRT and 30 days after. (Sorafenib will be escalated for both cohorts to determine maximum tolerated dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Sorafenib | To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Sorafenib and radiotherapy -/+ temozolomide patients with malignancies of the brain. | 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response rate (in those patients with measurable disease) | 30 days post-treatment |
| Prediction of 1-year Recurrence | Determine if an increase in urinary VEGF and MMP levels, from the end of treatment to a patient's 1-month follow-up examination, is predictive of 1-year recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Dicker, MD, PhD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
| Thomas Jefferson University Hospitals | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Temozolomide | Drug | For Cohort 2 - Gliomas only. |
|
|
| Radiotherapy | Radiation | Radiation Therapy (XRT) |
|
|
| 1 year post-treatment |
| Safety and Toxicity of Sorafenib | To evaluate the safety and toxicity profile of Sorafenib in combination with radiation therapy -/+ temozolomide | 30 days post-treatment |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |