Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Talampanel, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry NABTT-0304 IVAX-IXR-207-21-189, NCT00267592

Objectives

Primary

1. Determine the overall survival of patients with newly diagnosed glioblastoma multiforme treated concurrently with talampanel, radiotherapy, and temozolomide.

Secondary

1. Determine the toxicity of this regimen in these patients.
2. Determine the toxicity rate in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy or other biologic therapy for brain tumor, including any of the following:
  • Immunotoxin therapy
  • Immunoconjugate therapy
  • Antisense therapy
  • Peptide receptor antagonist therapy
  • Interferon therapy
  • Interleukin therapy
  • Tumor-infiltrating lymphocyte therapy
  • Lymphocyte-activated killer cell therapy
  • Gene therapy
• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy for brain tumor (including polifeprosan 20 with carmustine implant)
• No other concurrent chemotherapy

Endocrine therapy

• No prior hormonal therapy for brain tumor
• Prior glucocorticoid therapy allowed
• Patients must be maintained on a stable corticosteroid regimen for at least 5 days before study entry
• No concurrent hormonal therapy

Radiotherapy

• No prior radiotherapy for brain tumor
• No other concurrent radiotherapy, including intensity-modulated radiotherapy

Surgery

• Recovered from prior surgery
• No concurrent surgery

Other

• More than 10 days since prior enzyme-inducing anti-epileptic drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine
• More than 4 weeks since prior valproic acid
• No concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent valproic acid

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥100,000/mm³

Hepatic

• Bilirubin ≤1.5 mg/dL
• Transaminases ≤ 4 times upper limit of normal

Renal

• Creatinine ≤ 1.5 mg/dL

Other

• Mini Mental State Exam score ≥15
• No serious active infection requiring IV antibiotics
• No other serious medical illness that would preclude study participation
• No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 effective forms of contraception during and for 2 months after study participation

Expected Enrollment

A maximum of 60 patients will be accrued for this study within 10-20 months.

Outcomes

Overall survival
Overall failure rate

Toxicity

Outline

This is a multicenter study. Patients are stratified according to the use of cytochrome p450-inducing anticonvulsant drugs (yes vs no).

• Induction therapy: Patients undergo radiotherapy on days 1-5 . Patients also receive oral talampanel 3 times daily and oral temozolomide once daily on days 1-7. Courses repeat weekly for 6 weeks in the absence of unacceptable toxicity. Patients discontinuing talampanel due to excessive toxicity continue to receive radiotherapy and temozolomide until the completion of induction therapy.



• Maintenance therapy: Beginning immediately after the completion of induction therapy, patients receive oral talampanel 3 times daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive temozolomide once daily on days 1-5 in courses 2-7.

Patients are followed every 2 months.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Howard Fine, MD, Protocol chair		Ph: 301-402-6298
Stuart Grossman, MD, Protocol co-chair		Ph: 410-955-8837 Email: Grossman@jhmi.edu

Registry Information
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
Trial Start Date		2004-08-26
Registered in ClinicalTrials.gov		NCT00267592
Date Submitted to PDQ		2004-03-12
Information Last Verified		2006-05-17
NCI Grant/Contract Number		CA062475

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