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The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enzyme-inducing antiseizure drug | Experimental | A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talampanel | Drug | Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Talampanel-related toxicity | 29 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C085266 | talampanel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation Therapy (RT) 5 days a week + | Radiation |
|
| temozolomide(TMZ) 75mg | Drug | temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks |
|
| adjuvant TMZ 200mg | Drug | adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months. |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |