Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Glioma

Astrocytoma

Oligodendroglioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Neuroepithelioma

Anticonvulsants

All Drugs and Chemicals

Valproic: 10mg TID week 1, 25mg TID week 2, 35mg week 3

Non-enzyme-inducing anti-epileptic drugs: 25mg TID week 1, 35mg week 2, 50mg week 3

Enzyme-inducing anti-epileptic drugs: 35mg TID week 1, 505mg week 2, 75mg week 3

10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks

Talampanel

To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.

To determine the efficacy of Talampanel in patients with recurrent malignant glioma as measured by 6-month progression survival, as well as to obtain preliminary information regarding the spectrum of toxicities of the drug among this patient population.

Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas

A Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.

National Cancer Institute (NCI)

Teva Branded Pharmaceutical Products R&D, Inc.

Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

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 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 3 times daily (TID) for 6 weeks

temozolomide(TMZ) 75mg

adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.

adjuvant TMZ 200mg

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas	NCT00062504	Glioblastoma Mu... Anaplastic Astr... Anaplastic Olig... Anaplastic Mixe...	Talampanel	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Safety and Efficacy of Talampanel in Glioblastoma Multiforme	NCT00267592	Glioblastoma Mu...	Talampanel Radiation Thera... temozolomide(TM... adjuvant TMZ 20...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas	NCT00062504	Glioblastoma Mu... Anaplastic Astr... Anaplastic Olig... Anaplastic Mixe...	Talampanel	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Safety and Efficacy of Talampanel in Glioblastoma Multiforme	NCT00267592	Glioblastoma Mu...	Talampanel Radiation Thera... temozolomide(TM... adjuvant TMZ 20...	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas	NCT00062504	Glioblastoma Mu... Anaplastic Astr... Anaplastic Olig... Anaplastic Mixe...	Talampanel	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.
Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas	NCT00062504	Glioblastoma Mu... Anaplastic Astr... Anaplastic Olig... Anaplastic Mixe...	Talampanel	18 Years -	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for talampanel

Every month we try and update this database with for talampanel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for talampanel

Every month we try and update this database with for talampanel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for talampanel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.