Spots Global Cancer Trial Database for Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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Trial Identification
Brief Title: Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title: A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
Study ID: NCT00099125
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in 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: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
Saint Agnes Medical Center, Fresno, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
Providence Holy Cross Cancer Center, Mission Hills, California, United States
Pomona Valley Hospital Medical Center, Pomona, California, United States
Radiological Associates of Sacramento Medical Group, Inc., Sacramento, California, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine, New Haven, Connecticut, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
John B. Amos Community Cancer Center, Columbus, Georgia, United States
Regional Radiation Oncology Center at Rome, Rome, Georgia, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
St. Francis Hospital and Health Centers, Beech Grove, Indiana, United States
Tulane Cancer Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau, Cape Girardeau, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri, United States
Methodist Cancer Center at Methodist Hospital - Omaha, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Dartmouth - Hitchcock Concord, Concord, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, United States
Cooper Cancer Institute, Camden, New Jersey, United States
John F. Kennedy Medical Center, Edison, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Lipson Cancer and Blood Center at Rochester General Hospital, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Randolph Hospital, Asheboro, North Carolina, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital, Eden, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina, United States
Annie Penn Cancer Center, Reidsville, North Carolina, United States
Akron City Hospital, Akron, Ohio, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Radiation Oncology Center, Alliance, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Middletown Regional Hospital, Middletown, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Legacy Mount Hood Medical Center, Glesham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Institute of Oncology at Vilnius University, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC McKeesport, McKeesport, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Presbyterian, Pittsburgh, Pennsylvania, United States
UPMC St. Margaret, Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
UPMC - Shadyside, Pittsburgh, Pennsylvania, United States
UPMC - Passavant Hospital, Pittsburgh, Pennsylvania, United States
Cancer Center at St. Clair Memorial Hospital, Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburg, Pennsylvania, United States
Reading Hospital and Medical Center, West Reading, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
York Cancer Center at Wellspan Health, York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, 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
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
Dixie Regional Medical Center, St. George, Utah, United States
Green Mountain Oncology Group, Bennington, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Community Cancer Center at Rutland Regional Medical Center, Rutland, Vermont, United States
Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
North Star Lodge Cancer Center, Yakima, Washington, United States
St. Vincent Hospital, Green Bay, Wisconsin, 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
Community Memorial Hospital, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Frank S. Lieberman, MD
Affiliation: University of Pittsburgh
Role: STUDY_CHAIR
Name: Christina I. Tsien, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
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