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Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas Clinical research trials and Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas. Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas  Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
For Condition: Mixed Gliomas,adult anaplastic astrocytoma
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI),North Central Cancer Treatment Group,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and carmustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomizedphase III trial to study the effectiveness of radiation therapy combined with temozolomide or carmustine in treating patients who have anaplasticastrocytoma or mixed gliomas.
Details: OBJECTIVES: - Compare the overall survival and time to tumor progression in patients with anaplastic astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs carmustine vs temozolomide and carmustine (arm discontinued as of 8/15/02). - Compare the relative toxic effects of these regimens in these patients. - Correlate molecular analyses with overall survival and time to tumor progression in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior surgery (biopsy only vs resection). Phase I - Prior to initiating the randomization to 1 of 3 treatment arms in phase III, 15 patients are accrued to arm III. If 2 or more of the first 15 patients experience grade 3 or worse pulmonary toxicity OR if 5 or more of the first 15 patients experience grade 4-5 thrombocytopenia/neutropenia, then arm III treatment is discontinued. (Phase I closed as of 8/15/02) Phase II - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive oral temozolomide on days 1-5 of the first week of radiotherapy. Chemotherapy repeats every 4 weeks for a total of 12 courses. - Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a second course on days 56-58. Chemotherapy repeats every 8 weeks for a total of 6 courses. - Arm III: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV over 3 hours on day 5 and oral temozolomide (2 hours after completion of carmustine infusion) on days 1-5 of the first week of radiotherapy. Combination chemotherapy repeats every 8 weeks for 6 courses. (Arm III discontinued as of 8/15/02) Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I of the study and then a total of 454 patients (227 per treatment arm) will be accrued for phase III of the study within 4 years. (Phase I closed as of 8/15/02)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following: - Anaplastic oligoastrocytoma - Mixed oligodendroglial/astrocytic tumors - Oligodendroglial component must be no greater than 25% - No vascular proliferation and necrosis - Increased cellularity, pleomorphism, and nuclear atypia allowed - No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum) - Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible - Study therapy must begin within 6 weeks of diagnosis - No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges - Pathologic evidence of local meningeal infiltration by underlying tumor allowed PATIENT CHARACTERISTICS: Age: - 18 to 65 Performance status: - Karnofsky 60-100% Life expectancy: - At least 1 year Hematopoietic: - Hemoglobin at least 10 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - AST less than 2 times ULN - Alkaline phosphatase less than 2 times ULN Renal: - Blood urea nitrogen no greater than 25 mg/dL - Creatinine less than 1.5 times normal Pulmonary: - No pre-existing lung disease that, in the investigator's opinion, would preclude administration of carmustine or completion of therapy Other: - No other major medical illness or psychiatric impairment that would preclude study compliance - No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - No active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - See Disease Characteristics - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to brain or head and neck Surgery: - Not specified Other: - No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence is detected
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanChang, Study Chair, University of California, San Francisco
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Mercy Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Recruiting Michael Dougherty 412-232-7862
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Robert Share 708-915-6620
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Good Shepherd Hospital *Recruiting*
Barrington, Illinois, 60010
United States
Recruiting Contact Person 847-381-9600 x4811
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Contact Person 916-734-5800
St. Elizabeth Medical Center *Recruiting*
Edgewood, Kentucky, 41017
United States
Recruiting Michael Cross 859-344-2238
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Michael Samuels 305-674-2625
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Reading Hospital and Medical Center *Recruiting*
Reading, Pennsylvania, 19612-6052
United States
Recruiting Albert Yuen 610-988-8067
Louisiana State University Medical Center *Recruiting*
Lafayette, Louisiana, 70502-4016
United States
Recruiting Contact Person 337-261-6276
Baptist Regional Cancer Institute - Jacksonville *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Contact Person 904-202-7020
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
Creticos Cancer Center at Advocate Illinois Masonic Medical Center *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Contact Person 773-296-7089
Medical X-Ray Center *Recruiting*
Sioux Falls, South Dakota, 57105
United States
Recruiting Contact Person 605-336-0515
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
West Michigan Cancer Center *Recruiting*
Kalamazoo, Michigan, 49007
United States
Recruiting Contact Person 616-373-7488
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro, North Carolina, 27533
United States
Recruiting Contact Person 919-736-1110
Methodist Cancer Center at Methodist Hospital *Recruiting*
Indianapolis, Indiana, 46206-1367
United States
Recruiting Peter Garrett 317-926-3172
Akron City Hospital *Recruiting*
Akron, Ohio, 44304
United States
Recruiting William Demas 330-375-3557
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
McFarland Clinic, P.C. *Recruiting*
Ames, Iowa, 50010
United States
Recruiting Contact Person 515-239-4400
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Sioux Valley Hospital at University of South Dakota Medical Center *Recruiting*
Sioux Falls, South Dakota, 57117-5039
United States
Recruiting Contact Person 605-333-1000
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501
United States
Recruiting Contact Person 701-323-6000
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0385
United States
Recruiting William Mendenhall 352-265-0287
Paoli Memorial Hospital *Recruiting*
Paoli, Pennsylvania, 19301-1792
United States
Recruiting Conact Person 610-648-1637
Cedar Rapids Oncology Associates *Recruiting*
Cedar Rapids, Iowa, 52403
United States
Recruiting Contact Person 319-363-8303
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Via Christi Regional Medical Center - St. Joseph Campus *Recruiting*
Wichita, Kansas, 67214
United States
Recruiting Contact Person 316-268-5784
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
Bon Secours - St. Mary's Hospital *Recruiting*
Richmond, Virginia, 23226
United States
Recruiting George Trivette 804-281-8350
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Albert Einstein Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19141-3098
United States
Recruiting Sucha Asbell 215-456-6280
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Mark Gilbert 713-792-8288
Baptist Hospital of Miami *Recruiting*
Miami, Florida, 33256-2110
United States
Recruiting Andre Abitbol 305-596-6566
Foundation for Cancer Research and Education *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting David Brachman 602-274-4484
Enloe Cancer Center at Enloe Medical Center *Recruiting*
Chico, California, 95926
United States
Recruiting Contact Person 530-332-7380
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Arnold Markoe 305-243-4319
Mobile Infirmary Medical Center *Recruiting*
Mobile, Alabama, 36652-2144
United States
Recruiting Contact Person 251-435-2400
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Janice Ryu 916-734-8251
Mercy Hospital Cancer Center - Scranton *Recruiting*
Scranton, Pennsylvania, 18501
United States
Recruiting Contact Person 570-348-7940
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center *Recruiting*
Grand Junction, Colorado, 81502-1628
United States
Recruiting Douglas Rock 970-244-2442
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Paul Okunieff 585-275-5575
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
Anne Arundel Oncology Center *Recruiting*
Annapolis, Maryland, 21401
United States
Recruiting Angel Torano 443-481-5800
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Lutheran General Cancer Care Center *Recruiting*
Park Ridge, Illinois, 60068
United States
Recruiting John Chang 847-723-8030
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195-6043
United States
Recruiting David Schwartz 206-768-5356
Yakima Valley Memorial Hospital *Recruiting*
Yakima, Washington, 98902
United States
Recruiting Sean Cleary 509-574-3500
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Delaware County Memorial Hospital *Recruiting*
Drexel Hill, Pennsylvania, 19026
United States
Recruiting Rachelle Lanciano 610-284-8240
Poudre Valley Hospital *Recruiting*
Fort Collins, Colorado, 80524
United States
Recruiting Contact Person 970-495-7000
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Avera McKennan Hospital and University Health Center *Recruiting*
Sioux Falls, South Dakota, 57105-1080
United States
Recruiting Contact Person 605-322-3000
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905-0001
United States
Recruiting Michael Haddock 507-284-2511
Natalie Warren Bryant Cancer Center *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Contact Person 918-491-5878
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital *Recruiting*
Allentown, Pennsylvania, 18105
United States
Recruiting Victor Risch 610-402-0700
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
John F. Kennedy Medical Center *Recruiting*
Edison, New Jersey, 08818
United States
Recruiting Mark Macher 732-321-7167
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Contact Person 904-953-2000
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Benjamin Movsas 215-728-3631
Trinity Cancer Care Center *Recruiting*
Minot, North Dakota, 58701
United States
Recruiting Kevin Collins 701-857-3535
South Jersey Regional Cancer Center *Recruiting*
Millville, New Jersey, 08332
United States
Recruiting Joseph Fanelle 856-293-2910
Lankenau Cancer Center at Lankenau Hospital *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Contact Person 610-645-2680
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Marquette General Hospital *Recruiting*
Marquette, Michigan, 49855
United States
Recruiting Paul Thieme 906-225-3102
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Luis Souhami 514-934-8040 ext. 43163
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting James Wheeler 402-354-4104
Cancer Institute at Virginia Mason Medical Center *Recruiting*
Seattle, Washington, 98111
United States
Recruiting Huong Pham 206-223-2374
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Northwest Community Hospital *Recruiting*
Arlington Heights, Illinois, 60005
United States
Recruiting Arnold Herskovic 847-618-6576
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
Pocono Cancer Center *Recruiting*
East Stroudsburg, Pennsylvania, 18301
United States
Recruiting Michael Greenberg 570-476-3488
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Salem Hospital Regional Cancer Center *Recruiting*
Salem, Oregon, 97309-5014
United States
Recruiting Contact Person 503-561-5574
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Albert DeNittis 610-645-2433
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division *Recruiting*
Charleston, West Virginia, 25302
United States
Recruiting Contact Person 304-388-1552
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Walter Curran 215-955-6700
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Guthrie Medical Center *Recruiting*
Sayre, Pennsylvania, 18840
United States
Recruiting Contact Person 717-888-6666
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting William Sause 801-408-1146
MD Anderson Cancer Center Orlando *Recruiting*
Orlando, Florida, 32806-2134
United States
Recruiting Alan Forbes 407-643-3800
Additional Information:
Study ID Numbers: CDR0000067512; RTOG-9813,ECOG-R9813,NCCTG-RTOG-9813
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004259
Other Mixed Gliomas Studies:
1. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
2. Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma
3. BMS 247550 in Treating Patients With Recurrent Glioma
4. Vaccine Therapy in Treating Patients With Malignant Glioma
5. Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
Related Studies:
Other Mixed Gliomas Clinical Trials
Other Oregon Clinical Trials
Other Salem Clinical Trials
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
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