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Brief Title: Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Official Title: Phase I/II Trial of Imatinib Mesylate; (Gleevec; STI571) in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma
Study ID: NCT00049127
Brief Summary: This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To identify the maximum tolerated dose of imatinib (imatinib mesylate) in patients with recurrent oligodendroglioma and mixed oligoastrocytoma that are currently on enzyme inducing anticonvulsant therapy. (Study 1) II. To assess the efficacy of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas (with pathologic evidence of oligodendrogliomatous component) as measured by progression-free survival, response, and overall survival. (Study 2) III. To acquire pilot data on a patient group not traditionally eligible for recurrent oligodendroglioma and mixed oligoastrocytoma clinical trials (those having \> 2 prior chemotherapy regimens or 2 prior chemotherapy regimens for recurrent/progressive disease). (Study 3) IV. To examine the toxicity and safety of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas (with pathologic evidence of oligodendrogliomatous component). (Studies 1, 2, and 3) V. To perform a preliminary correlative study of 1p/19q alterations, alpha platelet-derived growth factor receptor (PDFGR) gene amplification and levels of related downstream signaling elements in tumor tissue, with clinical study endpoints. (Studies 1, 2, and 3) VI. To perform a descriptive correlative analysis of steady state pharmacokinetic data regarding imatinib and active metabolites with the study endpoints. (Studies 1, 2, and 3) OUTLINE: This is a phase I, dose-escalation study followed by a phase II and a pilot study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Bromenn Lifecare Center, Bloomington, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Illinois CancerCare Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex - Hospital, Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States
Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States
Vigliotti, Antonio, P.G. M.D. (UIA Investigator), Moline, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center Foundation, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Pekin Cancer Treatment Center, Pekin, Illinois, United States
Pekin Hospital, Pekin, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Illinois Oncology Research Association CCOP, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Sarah Culbertson Memorial Hospital, Rushville, Illinois, United States
Saint Margaret's Hospital, Spring Valley, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Carle Clinic-Urbana Main, Urbana, Illinois, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
Saint Anthony Regional Hospital, Carroll, Iowa, United States
Saint Luke's Hospital, Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Association, Cedar Rapids, Iowa, United States
Mercy Hospital, Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States
Mercy Capitol, Des Moines, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Medical Center - North Iowa, Mason City, Iowa, United States
Community Memorial Hospital, Missouri Valley, Iowa, United States
Burgess Memorial Hospital, Onawa, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Hospital District Sixth of Harper County, Anthony, Kansas, United States
Memorial Hospital of Arkansas City, Arkansas City, Kansas, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas - Ottawa, Ottawa, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Main Office, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Wichita CCOP, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Bixby Medical Center, Adrian, Michigan, United States
Hickman Cancer Center, Adrian, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP, Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Center for Hematology- Oncology of Southern Michigan PLC, Jackson, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Mercy Memorial Hospital, Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Medini, Eitan MD (UIA Investigator), Alexandria, Minnesota, United States
Brainerd Medical Center Inc, Brainerd, Minnesota, United States
Essentia Health Saint Joseph's Medical Center, Brainerd, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Essentia Health Cancer Center, Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States
Miller-Dwan Hospital, Duluth, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Etzell, Paul S MD (UIA Investigator), Fergus Falls, Minnesota, United States
Swenson, Wade II, MD (UIA Investigator), Fergus Falls, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Litchfield, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Chippewa County - Montevideo Hospital, Montevideo, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Metro-Minnesota NCI Community Oncology Research Program, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Saint Joseph's Hospital - Healtheast, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Adult and Pediatric Urology PLLP, Sartell, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota, United States
Woodwinds Health Campus, Woodbury, Minnesota, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings, Billings, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Deaconess Medical Center, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Internal Medicine of Bozeman, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Berdeaux, Donald MD (UIA Investigator), Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Glacier Oncology PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Eastern Montana Cancer Center, Miles City, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Montana Cancer Specialists, Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Fremont Area Medical Center, Fremont, Nebraska, United States
Bryan LGH Medical Center West, Lincoln, Nebraska, United States
Bryan LGH Medical Center East, Lincoln, Nebraska, United States
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Midlands Community Hospital, Papillion, Nebraska, United States
Mount Sinai Medical Center, New York, New York, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Southeast Cancer Consortium-Upstate NCORP, Winston-Salem, North Carolina, United States
Mid Dakota Clinic, Bismarck, North Dakota, United States
Saint Alexius Medical Center, Bismarck, North Dakota, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, United States
North Coast Cancer Care-Clyde, Clyde, Ohio, United States
Hematology Oncology Center Incorporated, Elyria, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Fremont Memorial Hospital, Fremont, Ohio, United States
Cole, Sharon, K. M.D. (UIA Investigator), Kenton, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Saint Luke's Hospital, Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center, Maumee, Ohio, United States
Fisher-Titus Medical Center, Norwalk, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States
Firelands Regional Medical Center, Sandusky, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Saint Vincent Mercy Medical Center, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Mercy Saint Anne Hospital, Toledo, Ohio, United States
Stark, Michael, Edward. M.D. (UIA Investigator), Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
Medical Center Clinic-Butler Office, Butler, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Sharon Regional Cancer Center, Hermitage, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Medical Center Clinic-Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital, Sayre, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
AnMed Health Hospital, Anderson, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford NCI Community Oncology Research Program of the North Central Plains, Sioux Falls, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States
Medical X-Ray Center, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: Kurt Jaeckle, MD
Affiliation: Mayo
Role: STUDY_CHAIR