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Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical research trials and Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme clinical trial. Participants frequently get the best healthcare available for their Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme  Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme,Mixed Gliomas
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickWen, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting David Schiff 434-982-4415
Brigham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-732-6081
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting John Henson 617-724-8770
Additional Information:
Study ID Numbers: CDR0000257587; NCI-G02-2118,DFCI-00302,CELGENE-2000-P-002521/1
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047294
Other Mixed Gliomas Studies:
1. Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
2. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
3. Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
4. CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
5. Taurolidine in Treating Patients With Recurrent or Progressive Glioma
Related Studies:
Other Mixed Gliomas Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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