A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
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.
Interventional
Primary Purpose: Treatment
Michael A. Vogelbaum, MD, PhD
Study Chair
The Cleveland Clinic
United States: Federal Government
CDR0000069270
NCT00033280
July 2002
Name | Location |
---|---|
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 |