Spots Global Cancer Trial Database for Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
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Trial Identification
Brief Title: Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Official Title: A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Study ID: NCT00033280
Conditions
Study Description
Brief Summary: 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 anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
University of Miami Sylvester Cancer Center, Miami, Florida, United States
Baptist Hospital of Miami, Miami, Florida, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Wayne Memorial Hospital, Inc., Goldsboro, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Akron City Hospital, Akron, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Mount Carmel West Hospital, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Mercy Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Anderson Area Cancer Center, Anderson, South Carolina, United States
Cottonwood Hospital Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo, Provo, Utah, United States
Dixie Regional Medical Center, Saint George, Utah, United States
University of Utah Health Sciences Center, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Contact Details
Name: Michael A. Vogelbaum, MD, PhD
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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