Safety and Efficacy of Talampanel in Glioblastoma Multiforme
NCT ID: NCT00267592
Last Updated: 2016-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2005-12-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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enzyme-inducing antiseizure drug
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.
Talampanel
Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
Radiation Therapy (RT) 5 days a week +
temozolomide(TMZ) 75mg
temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
adjuvant TMZ 200mg
adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
Interventions
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Talampanel
Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
Radiation Therapy (RT) 5 days a week +
temozolomide(TMZ) 75mg
temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
adjuvant TMZ 200mg
adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
Eligibility Criteria
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Inclusion Criteria
* Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
* Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
* Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
* Patients must have a Karnofsky performance of at least 60% or more.
Exclusion Criteria
* Patients receiving concurrent chemotherapeutics or investigational agents.
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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IXR-207-21-189 / NABTT 0304
Identifier Type: -
Identifier Source: org_study_id
NCT00082992
Identifier Type: -
Identifier Source: nct_alias
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