Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Adult Anaplastic Oligodendroglioma, Adult Mixed Glioma, Adult Oligodendroglioma
About this trial
This is an interventional treatment trial for Adult Anaplastic Oligodendroglioma
Eligibility Criteria
Inclusion Criteria: Study 1 Arm C: Currently on anticonvulsants which can induce cytochrome p450 (phenytoin, carbamazepine, barbiturates, primidone and if unsure contact study chair) =< 2 prior chemotherapy regimens (with maximum of 1 prior chemotherapy regimen for recurrent disease) Study 2 Arms A and B: On or off anticonvulsants =< 2 prior chemotherapy regimens (with maximum of 1 prior chemotherapy regimen for recurrent disease) Study 3 Arms D and E: On or off anticonvulsants > 2 chemotherapy regimens or 2 prior chemotherapy regimens for progressive/recurrent disease All Arms: Histological confirmation of a grade 2-4 oligodendroglioma, or mixed oligoastrocytoma grade 2-4 containing oligodendrogliomatous component on central pathology review prior to study registration, and a diagnosis of recurrence; tissues from all available prior surgeries should be sent, in particular those from time of initial diagnosis Measurable or evaluable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan Fixed dose of corticosteroids (or no corticosteroids) for at least 1 week prior to the pre-study baseline scan Patients undergoing surgery for initial or progressive disease, must be at least 2 weeks from the date of surgery, must have recovered from the effects of their surgery, and must have unequivocal tumor growth on the pre-study baseline neuroimaging study as compared to the first post-operative scan, unless there is a separate lesion or residual disease compatible with tumor that is not within the surgical bed Unequivocal evidence of tumor progression by MRI or CT scan performed =< 21days prior to study registration Must have failed surgery/radiotherapy (RT) and Temozolomide or nitrosourea based therapy >= 12 weeks since the completion of RT Absolute neutrophil count (ANC) >= 1500/mm^3 Platelets (PLT) >= 100,000/mm^3 Hemoglobin (Hgb) >= 9 g/dL Total bilirubin =< 1.5 mg/dL Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x upper limit of normal (ULN) Creatinine =< 2.0 mg/dL Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 >= 6 weeks since the last day of nitrosourea-based chemotherapy prior to study entry >= 4 weeks from any investigational agents prior to study entry >= 4 weeks from other chemotherapy prior to study entry >= 2 weeks from vincristine and biologic non-cytotoxic agents, e.g., tamoxifen, thalidomide, cis-retinoic acid, interferon, etc, prior to study entry Patients or designated individual(s) with durable medical power of attorney for the patient must be able to provide informed, written consent, and complete any required study questionnaire(s) within the specifications of this study Exclusion Criteria: All Arms Receiving warfarin or heparin Received prior stereotactic radiosurgery, interstitial brachytherapy, or interstitial chemotherapy including carmustine (BCNU) wafers unless there is a separate lesion on MRI, which is not part of the previous treatment field Active uncontrolled infection History of myocardial infarction =< 6 months or congestive heart failure (CHF) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; patients must have a New York Heart Association (NYHA) of class II or less; (NYHA class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities; class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion; class III: patients with marked limitation of activity; they are comfortable only at rest; class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest) Other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the interpretation of potential drug-induced toxicities Women of child-bearing potential, pregnant or nursing; such patients must have a negative pregnancy test (b-HCG) =< 7 days prior to study registration Men or women of childbearing potential, not willing to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.); the efficacy of oral contraceptives may be decreased in patients who receive p450-inducing anticonvulsants; for these patients, use of a second mode of contraception is recommended; patients of childbearing potential must utilize effective contraception and avoid becoming pregnant or fathering a child for 6 months after completing study drug Other active malignancy, besides skin carcinomas (must not be melanoma) Concomitant serious immunocompromised status (other than that related to concomitant steroids); patients that are human immunodeficiency virus (HIV) positive are eligible, provided that there is no other reason for exclusion, based on the eligibility as outlined elsewhere in this section Significant intratumoral hemorrhage on baseline MRI or CT, or other history of significant intratumoral hemorrhage
Sites / Locations
- Mayo Clinic in Arizona
- Saint Francis Hospital and Medical Center
- Mayo Clinic in Florida
- Rush - Copley Medical Center
- Bromenn Lifecare Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare Galesburg
- Western Illinois Cancer Treatment Center
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Kewanee Hospital
- Mcdonough District Hospital
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Valley Radiation Oncology
- Perry Memorial Hospital
- Sarah Culbertson Memorial Hospital
- Saint Margaret's Hospital
- Carle Cancer Center
- Carle Clinic-Urbana Main
- Franciscan Saint Anthony Health-Michigan City
- McFarland Clinic PC-William R Bliss Cancer Center
- Constantinou, Costas L MD (UIA Investigator)
- Saint Anthony Regional Hospital
- Saint Luke's Hospital
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Alegent Health Mercy Hospital
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Mercy Medical Center - North Iowa
- Community Memorial Hospital
- Burgess Memorial Hospital
- Siouxland Regional Cancer Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Hospital District Sixth of Harper County
- Memorial Hospital of Arkansas City
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Ottawa
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium CCOP
- Oakwood Hospital and Medical Center
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Allegiance Health
- Center for Hematology- Oncology of Southern Michigan PLC
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Medini, Eitan MD (UIA Investigator)
- Brainerd Medical Center Inc
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Etzell, Paul S MD (UIA Investigator)
- Swenson, Wade II, MD (UIA Investigator)
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- Chippewa County - Montevideo Hospital
- North Memorial Medical Health Center
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro-Minnesota NCI Community Oncology Research Program
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Adult and Pediatric Urology PLLP
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Woodwinds Health Campus
- Montana Cancer Consortium NCORP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Frontier Cancer Center and Blood Institute-Billings
- Billings Clinic Cancer Center
- Deaconess Medical Center
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Internal Medicine of Bozeman
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- Fremont Area Medical Center
- Bryan LGH Medical Center West
- Bryan LGH Medical Center East
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Missouri Valley Cancer Consortium
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- Midlands Community Hospital
- Mount Sinai Medical Center
- Rutherford Hospital
- Southeast Cancer Consortium-Upstate NCORP
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Toledo Clinic Cancer Centers-Bowling Green
- North Coast Cancer Care-Clyde
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Blanchard Valley Hospital
- Fremont Memorial Hospital
- Cole, Sharon, K. M.D. (UIA Investigator)
- Lima Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Stark, Michael, Edward. M.D. (UIA Investigator)
- Toledo Clinic Cancer Centers-Toledo
- Fulton County Health Center
- Lehigh Valley Hospital-Cedar Crest
- Medical Center Clinic-Butler Office
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Sharon Regional Cancer Center
- Allegheny General Hospital
- Medical Center Clinic-Allegheny General Hospital
- Guthrie Medical Group PC-Robert Packer Hospital
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- AnMed Health Hospital
- Spartanburg Medical Center
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Sanford NCI Community Oncology Research Program of the North Central Plains
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- University of Virginia Cancer Center
- Fredericksburg Oncology Inc
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase II (Group 1)
Phase II (Group 2)
Patients receive imatinib mesylate PO, at the MTD determined in phase I, BID for 4 weeks.
Patients receive standard-dose imatinib mesylate PO BID for 4 weeks.