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Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas Clinical research trials and Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas. Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas clinical trial. Human subjects often get the best healthcare available for their Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "T" Clinical Trials Conditions > Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas



Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

For Condition: Mixed Gliomas,adult anaplastic oligodendroglioma
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplasticoligodendrogliomas or mixed anaplastic oligoastrocytomas.
Details: OBJECTIVES: - Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy. - Determine the toxicity of this regimen in these patients. - Determine the survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response [PR] vs complete response [CR]). Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR. Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy. Patients with CR after completion of neoadjuvant temozolomide undergo observation. Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma - Unifocal or multifocal disease - Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy - No equivocal oligodendroglial element - No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum) - No spinal cord tumors - No evidence of spinal drop metastasis or spread to noncontiguous meninges PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - Zubrod 0-1 Life expectancy: - More than 12 weeks Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than 2 times normal - AST no greater than 3 times normal - Alkaline phosphatase no greater than 2 times normal Renal: - Creatinine no greater than 1.5 times normal Other: - No active infection - No other medical problems that would preclude study participation - No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior chemotherapy for this malignancy - No prior temozolomide Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the brain, head, or neck Surgery: - At least 14 days since prior surgery requiring general anesthesia
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelVogelbaum,  Study Chair,  Cleveland Clinic Cancer Center

Anderson Area Cancer Center *Recruiting*
Anderson,  South Carolina,  29621-5705
United States
Recruiting Contact  Person 800-613-5631

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting Lawrence  Berk 614-566-9506

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse,  Wisconsin,  54601
United States
Recruiting Philip  Doescher 608-782-7300 ext. 2588

University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98195-6043
United States
Recruiting David  Schwartz 206-768-5356

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Bernd  Scheithauer 507-284-2511

Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro,  North Carolina,  27533
United States
Recruiting Contact  Person 919-736-1110

Dixie Regional Medical Center *Recruiting*
St. George,  Utah,  84770
United States
Recruiting Ray  Richards 801-688-4175

McKay-Dee Hospital Center *Recruiting*
Ogden,  Utah,  84403
United States
Recruiting Contact  Person 801-627-2800

Mobile Infirmary Medical Center *Recruiting*
Mobile,  Alabama,  36652-2144
United States
Recruiting Contact  Person 251-435-2400

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Elizabeth  Gore 414-805-4465

Strecker Cancer Center at Marietta Memorial Hospital *Recruiting*
Marietta,  Ohio,  45750-1635
United States
Recruiting Contact  Person 740-374-1400

Saint John Regional Hospital *Recruiting*
Saint John,  New Brunswick,  E2L 4L2
Canada
Recruiting John  Carson 506-648-6884

Mount Carmel West Hospital *Recruiting*
Columbus,  Ohio,  43222
United States
Recruiting Contact  Person 614-234-5000

Licking Memorial Hospital *Recruiting*
Newark,  Ohio,  43055-2899
United States
Recruiting Contact  Person 740-348-4000

Baptist Hospital of Miami *Recruiting*
Miami,  Florida,  33256-2110
United States
Recruiting Andre  Abitbol 305-596-6566

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

University of Miami Sylvester Cancer Center *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Arnold  Markoe 305-243-4319

Foundation for Cancer Research and Education *Recruiting*
Phoenix,  Arizona,  85013
United States
Recruiting David  Brachman 602-274-4484

Cottonwood Hospital Medical Center *Recruiting*
Murray,  Utah,  84107
United States
Recruiting Contact  Person 801-314-5300

Akron City Hospital *Recruiting*
Akron,  Ohio,  44304
United States
Recruiting William  Demas 330-375-3557

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792
United States
Recruiting Minesh  Mehta 608-263-8500

Grady Memorial Hospital *Recruiting*
Delaware,  Ohio,  43015
United States
Recruiting Contact  Person 740-369-8711

Fairfield Medical Center *Recruiting*
Lancaster,  Ohio,  43130
United States
Recruiting Contact  Person 800-548-2627

Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville,  Florida,  32610-0385
United States
Recruiting William  Mendenhall 352-265-0287

LDS Hospital *Recruiting*
Salt Lake City,  Utah,  84143
United States
Recruiting William  Sause 801-408-1146

CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale,  Arizona,  85259-5404
United States
Recruiting Contact  Person 480-301-9875

Utah Valley Regional Medical Center - Provo *Recruiting*
Provo,  Utah,  84604
United States
Recruiting Tarlton  Blair 801-373-7850 ext. 2480

Adena Regional Medical Center *Recruiting*
Chillicothe,  Ohio,  45601
United States
Recruiting Contact  Person 740-779-7500

Riverside Methodist Hospital *Recruiting*
Columbus,  Ohio,  43214
United States
Recruiting Contact  Person 614-566-5000

CCOP - Toledo Community Hospital *Recruiting*
Toledo,  Ohio,  43623-3456
United States
Recruiting Paul  Schaefer 419-843-6147

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114-4199
United States
Recruiting James  Wheeler 402-354-4104

University of Utah Health Sciences Center *Recruiting*
Salt Lake City,  Utah,  84132
United States
Recruiting Cherie  Hayostek 801-585-3593

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Contact  Person 904-953-2000

Monmouth Medical Center *Recruiting*
Long Branch,  New Jersey,  07740-6395
United States
Recruiting Smitha  Gollamudi 732-923-6890

Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15219
United States
Recruiting Michael  Dougherty 412-232-7862

Rutherford Hospital *Recruiting*
Rutherfordton,  North Carolina,  28139-0000
United States
Recruiting Contact  Person 828-286-5000


Additional Information:
Study ID Numbers:
  CDR0000069270;  RTOG-DEV-1080,RTOG-BR-0131
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033280

Other Adult Anaplastic Oligodendroglioma Studies:
1. Carmustine in Treating Patients With Recurrent Malignant Glioma

2. Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

3. Imatinib Mesylate in Treating Patients With Gliomas

4. Immunotoxin Therapy in Treating Patients With Malignant Glioma

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

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