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Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma Clinical research trials and Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma clinical trial. Human subjects often get the best healthcare possible for their Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma  Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
For Condition: adult anaplastic oligodendroglioma,adult glioblastoma multiforme,adult anaplastic astrocytoma,recurrent adult brain tumor,Mixed Gliomas
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractorymalignantglioma.
Details: OBJECTIVES: - Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma. - Determine the overall survival of patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the radiographic response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified - Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection - Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days - Failed prior radiotherapy - Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 2 months Hematopoietic - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 9 g/dL - 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 - Creatinine less than 1.5 times upper limit of normal (ULN) OR - BUN 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 - No peripheral neuropathy grade 2 or greater - No active infection - No other serious concurrent medical illness - No concurrent illness that may obscure toxicity or dangerously alter drug metabolism - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - Must participate in the System for Thalidomide Education and Prescribing Safety program - 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 oral thalidomide or celecoxib for more than 2 months duration Chemotherapy - No prior oral etoposide or cyclophosphamide for more than 2 months duration - Prior standard-dose IV etoposide and cyclophosphamide allowed Endocrine therapy - See Disease Characteristics - Concurrent steroids allowed Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery - See Disease Characteristics - Prior surgery for relapsed or refractory disease allowed - Recovered from prior surgery - No concurrent surgery Other - No other concurrent investigational agents or treatment - No other concurrent anticancer therapy - Concurrent antiseizure medications allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickWen, Study Chair, Dana-Farber/Harvard Cancer Center
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Tracy Batchelor 617-724-8770
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 434-982-4115
Brigham and Women's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-732-6081
Additional Information:
Study ID Numbers: CDR0000257584; CELGENE-2001-P-001757/3,DFCI-01278,NCI-G02-2117
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047281
Other Adult Anaplastic Astrocytoma Studies:
1. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
2. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
3. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Astrocytoma
5. Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
Related Studies:
Other adult anaplastic astrocytoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
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