Phase I/II Trial Of Imatinib Mesylate; (Gleevec; STI571) In Treatment Of Recurrent Oligodendroglioma And Mixed Oligoastrocytoma
OBJECTIVES:
I. Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent
oligodendroglioma or mixed oligoastrocytoma who are currently on enzyme-inducing
anticonvulsant therapy.
II. Determine the efficacy of imatinib mesylate, as measured by response, survival, and
progression-free survival, in patients with recurrent oligodendroglioma or mixed
oligoastrocytoma.
III. Compare pilot data of patients who have undergone > 2 prior chemotherapy regimens for
recurrent, progressive, or mixed oligodendroglioma with traditional patients with recurrent
or mixed oligodendroglioma.
IV. Determine the toxicity and safety of this drug in these patients. V. Correlate,
preliminarily, 1p/19q alterations, alpha-PDFGR gene amplification, and levels of related
downstream signaling elements in tumor tissue with clinical response in patients treated
with this drug.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II and a
pilot study.
PHASE I: Patients receive oral imatinib mesylate twice daily for 4 weeks. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
PHASE II:
GROUP 1 (CONCURRENT ENZYME-INDUCING ANTICONVULSANTS [EIACs]): Patients receive oral imatinib
mesylate, at the MTD determined in phase I, twice daily for 4 weeks.
GROUP 2 (NON-EIACs): Patients receive oral standard-dose imatinib mesylate twice daily for 4
weeks.
In both groups, treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity.
PILOT STUDY: Patients are stratified and assigned to treatment groups as in phase II.
Patients receive oral imatinib as in phase II.
Patients are followed every 2 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of imatinib mesylate when given to patients who are receiving EIACs, defined as the highest safely tolerated dose level where, at most, 1 of 6 patients experiences DLT, graded according to CTCAE v4.0 (Phase I)
Up to 4 weeks
Yes
Kurt Jaeckle
Principal Investigator
North Central Cancer Treatment Group
United States: Food and Drug Administration
NCI-2011-01576
NCT00049127
June 2003
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Hurley Medical Center | Flint, Michigan 48503 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Great Falls Clinic | Great Falls, Montana 59405 |
Mount Sinai Medical Center | New York, New York 10029 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Eastern Montana Cancer Center | Miles City, Montana 59301 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Eureka Hospital | Eureka, Illinois 61530 |
Cancer Center of Kansas - Ottawa | Ottawa, Kansas 66067 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
BroMenn Lifecare Center | Bloomington, Illinois 61701-3081 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Pekin Hospital | Pekin, Illinois 61554 |
Saint Anthony Regional Hospital | Carroll, Iowa 51401 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Community Memorial Hospital | Missouri Valley, Iowa 51555-1199 |
Bixby Medical Center | Adrian, Michigan 49221 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Fremont Area Medical Center | Fremont, Nebraska 68025-2387 |
Bryan LGH Medical Center East | Lincoln, Nebraska 68506 |
Saint Luke's Hospital | Maumee, Ohio 43537 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Alegent Health Mercy Hospital | Council Bluffs, Iowa 51503 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
University of Virginia | Charlottesville, Virginia 22908 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Toledo Clinic | Oregon, Ohio 43616 |
Mid Dakota Clinic | Bismarck, North Dakota 58501 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Oncology Associates | Cedar Rapids, Iowa 52403 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Intercommunity Cancer Center | Galesburg, Illinois 61401 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Vigliotti, Antonio, P.G. M.D. (UIA Investigator) | Moline, Illinois 61265 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Sarah Culbertson Memorial Hospital | Rushville, Illinois 62681 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
Cedar Rapids Oncology Association | Cedar Rapids, Iowa 52403 |
Mercy Hospital | Cedar Rapids, Iowa 52403 |
Saint Luke's Hospital | Cedar Rapids, Iowa 52402 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Capitol | Des Moines, Iowa 50307 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Burgess Memorial Hospital | Onawa, Iowa 51040 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Siouxland Hematology - Oncology Associates | Sioux City, Iowa 51101 |
Memorial Hospital of Arkansas City | Arkansas City, Kansas 67005 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Hickman Cancer Center | Adrian, Michigan 49221 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Brainerd Medical Center Inc | Brainerd, Minnesota 56401 |
Saint Joseph's Medical Center | Brainerd, Minnesota 56401 |
Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Saint Joseph's Hospital - Healtheast | Saint Paul, Minnesota 55102 |
Adult and Pediatric Urology PLLP | Sartell, Minnesota 56377 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Deaconess Medical Center | Billings, Montana 59107 |
Billings Clinic | Billings, Montana 59107-7000 |
Internal Medicine of Bozeman | Bozeman, Montana 59715 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Saint Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
Lincoln Medical Education Foundation Cancer Resource Center | Lincoln, Nebraska 68510 |
Midlands Community Hospital | Papillion, Nebraska 68046 |
Saint Alexius Medical Center | Bismarck, North Dakota 58501 |
Medcenter One Health Systems | Bismarck, North Dakota 58501 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Cole, Sharon, K. M.D. (UIA Investigator) | Kenton, Ohio 43326 |
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee, Ohio 43537 |
Saint Charles Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
Mercy Cancer Center at Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
University of Toledo | Toledo, Ohio 43614 |
The Toledo Hospital | Toledo, Ohio 43606 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Community Health Partners Regional Medical Center | Elyria, Ohio 44035 |
Stark, Michael, Edward. M.D. (UIA Investigator) | Toledo, Ohio 43623 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Center for Hematology- Oncology of Southern Michigan PLC | Jackson, Michigan 49201 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
Medical Center Clinic-Butler Office | Butler, Pennsylvania 16001 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Sharon Regional Cancer Center | Hermitage, Pennsylvania 16148 |
Medical Center Clinic-Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |