Safety and Efficacy of Talampanel in Glioblastoma Multiforme - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by (Responsible Party):	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00267592

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: Talampanel	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:

Drug Information available for: Temozolomide GYKI 53773

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Talampanel-related toxicity [ Time Frame: 29 months ] [ Designated as safety issue: Yes ]

Enrollment:	72
Study Start Date:	December 2005
Study Completion Date:	February 2011
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Talampanel Radiation Therapy (RT) 5 days a week + temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks. One month later, adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months. Talampanel was administered orally TID beginning the first day of RT + TMZ and continued until there was talampanel-related toxicity or tumor progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00267592 History of Changes
Obsolete Identifiers:	NCT00082992
Other Study ID Numbers:	IXR-207-21-189 / NABTT 0304
Study First Received:	December 19, 2005
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012