A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
OBJECTIVES:
- Compare overall survival of patients with newly diagnosed supratentorial glioblastoma
multiforme treated with radiotherapy and temozolomide followed by temozolomide and
irinotecan with historical controls from the RTOG database.
- Determine the short- and long-term toxicity of this regimen in these patients.
- Determine progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6
weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7
days a week, for 6 weeks.
- Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of
chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral
temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year
in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Overall survival
No
Frank S. Lieberman, MD
Study Chair
University of Pittsburgh
United States: Federal Government
CDR0000389229
NCT00099125
November 2004
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
John F. Kennedy Medical Center | Edison, New Jersey 08818 |
Community Medical Center | Toms River, New Jersey 08755 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
LDS Hospital | Salt Lake City, Utah 84143 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Cancer Institute of New Jersey at the Cooper University Hospital | Camden, New Jersey 08103-1489 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
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 New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven, Connecticut 06520-8064 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
UPMC St. Margaret | Pittsburgh, Pennsylvania 15215 |
Providence Holy Cross Cancer Center | Mission Hills, California 91346-9600 |
Pomona Valley Hospital Medical Center | Pomona, California 91767 |
Radiological Associates of Sacramento Medical Group, Inc. | Sacramento, California 95815 |
St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Tulane Cancer Center | New Orleans, Louisiana 70112 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Randolph Hospital | Asheboro, North Carolina 27203 |
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital | Eden, North Carolina 27288 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland, Oregon 97210 |
Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital | Allentown, Pennsylvania 18105 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Saint Agnes Medical Center | Fresno, California 93720-3397 |
Dartmouth - Hitchcock Concord | Concord, New Hampshire 03301 |
York Cancer Center at Wellspan Health | York, Pennsylvania 17403 |
Community Cancer Center at Rutland Regional Medical Center | Rutland, Vermont 05701 |
Lipson Cancer and Blood Center at Rochester General Hospital | Rochester, New York 14621 |
John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
North Star Lodge Cancer Center | Yakima, Washington 98902 |
UPMC Cancer Center at UPMC Presbyterian | Pittsburgh, Pennsylvania 15213 |
Radiation Oncology Center | Alliance, Ohio 44601 |
Cancer Institute of Cape Girardeau | Cape Girardeau, Missouri 63703 |
UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
UPMC - Shadyside | Pittsburgh, Pennsylvania 15213-2582 |
UPMC McKeesport | McKeesport, Pennsylvania 15132 |
Cancer Center at St. Clair Memorial Hospital | Pittsburgh, Pennsylvania 15243 |
UPMC - Passavant Hospital | Pittsburgh, Pennsylvania 15237 |