Clinical trial · Interventional
Safety and Efficacy of Talampanel in Glioblastoma Multiforme
A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00267592CI-TRIAL-00022301completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant TMZ 200mg | Drug | — | UNRESOLVED |
| Radiation Therapy (RT) 5 days a week + | Radiation | — | UNRESOLVED |
| Talampanel | Drug | — | UNRESOLVED |
| temozolomide(TMZ) 75mg | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- enzyme-inducing antiseizure drug
- description
- 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.
- interventionNames
- Drug: Talampanel
- Radiation: Radiation Therapy (RT) 5 days a week +
- Drug: temozolomide(TMZ) 75mg
- Drug: adjuvant TMZ 200mg
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months
Secondary outcomes (1)
- measure
- Talampanel-related toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 years of age * 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 with serious concurrent infection or medical illness. * Patients receiving concurrent chemotherapeutics or investigational agents.
References
Publications (0)
Data not yet available
No reference posted for this study.