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Home > "T" Clinical Trials Conditions > Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Not yet recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as talampanel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining talampanel with radiation therapy in treating patients who have newly-diagnosedglioblastoma multiforme.
Details: OBJECTIVES: Primary - Determine the overall survival of patients with newly diagnosed glioblastoma multiforme treated concurrently with talampanel and radiotherapy. Secondary - Determine the toxicity of this regimen in these patients. - Determine the toxicity rate in patients treated with this regimen. 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 once daily on days 1-5. Beginning on day 1 of radiotherapy, patients receive oral talampanel 3 times daily on days 1-7. Treatment repeats weekly for 6 weeks. - 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 are followed every 2 months. PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study within 10-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - WBC 3,000/mm^3 - Hemoglobin 10 g/dL - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 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 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardFine, Study Chair, Neuro-Oncology Branch
Additional Information:
Study ID Numbers: CDR0000361755; NABTT-0304,IVAX-IXR-207-21-189
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082992
Other Adult Glioblastoma Multiforme Studies:
1. Pyrazoloacridine Followed by Radiation Therapy in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme
2. Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme
3. Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma
4. ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
5. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
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Talampanel and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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