Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed Description
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OBJECTIVES: Determine the efficacy of adjuvant temozolomide, thalidomide, and celecoxib after radiotherapy, in terms of time to tumor progression and overall survival, in patients with newly diagnosed glioblastoma multiforme. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Official Title
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Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: celecoxib
* Drug: temozolomide
* Drug: thalidomide
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma Completed standard external beam radiotherapy within the past 5 weeks Stable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 4 months Hematopoietic Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No history of bleeding disorder Hepatic Bilirubin less than 1.5 mg/dL SGPT less than 2.5 times normal Alkaline phosphatase less than 2.5 times normal Renal BUN less than 1.5 times upper limit of normal (ULN) OR Creatinine less than 1.5 times ULN Cardiovascular No deep vein thrombosis within the past 3 weeks (must be clinically stable) Pulmonary No pulmonary embolism within the past 3 weeks (must be clinically stable) Other Must participate in System for Thalidomide Education and Prescribing Safety program No peripheral neuropathy grade 2 or greater No active infection No concurrent illness that may obscure toxicity or dangerously alter drug metabolism No other serious concurrent illness No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy No prior thalidomide No concurrent immunotherapy No concurrent prophylactic filgrastim (G-CSF) Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery No concurrent surgery Other No other concurrent anticancer therapy No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: temozolomide|nan|
|Drug: thalidomide|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult mixed glioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma