A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
- 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
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.
Primary Purpose: Treatment
Michael A. Vogelbaum, MD, PhD
The Cleveland Clinic
United States: Federal Government
|Akron City Hospital||Akron, Ohio 44304|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center||La Crosse, Wisconsin 54601|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Baptist Hospital of Miami||Miami, Florida 33176-2197|
|CCOP - Columbus||Columbus, Ohio 43206|
|Mercy Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15219|
|Dixie Regional Medical Center||Saint George, Utah 84770|
|LDS Hospital||Salt Lake City, Utah 84143|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|CCOP - Columbia River Oncology Program||Portland, Oregon 97225|
|Utah Valley Regional Medical Center - Provo||Provo, Utah 84604|
|Foundation for Cancer Research and Education||Phoenix, Arizona 85013|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|University of Utah Health Sciences Center||Salt Lake City, Utah 84132|
|Mobile Infirmary Medical Center||Mobile, Alabama 36640-0460|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha||Omaha, Nebraska 68114-4199|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|Adena Regional Medical Center||Chillicothe, Ohio 54601|
|Mount Carmel West Hospital||Columbus, Ohio 43222|
|Grady Memorial Hospital||Delaware, Ohio 43015|
|Fairfield Medical Center||Lancaster, Ohio 43130|
|Strecker Cancer Center at Marietta Memorial Hospital||Marietta, Ohio 45750|
|Cottonwood Hospital Medical Center||Murray, Utah 84107|
|McKay-Dee Hospital Center||Ogden, Utah 84403|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Mayo Clinic||Jacksonville, Florida 32224|
|Shands Cancer Center at the University of Florida Health Science Center||Gainesville, Florida 32610-0296|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|
|University of Miami Sylvester Cancer Center||Miami, Florida 33136|
|Rutherford Hospital||Rutherfordton, North Carolina 28139|
|Wayne Memorial Hospital, Inc.||Goldsboro, North Carolina 27533|
|Riverside Methodist Hospital||Columbus, Ohio 43214|
|Licking Memorial Hospital||Newark, Ohio 43055-2899|
|Anderson Area Cancer Center||Anderson, South Carolina 29621-5705|