Know Cancer

forgot password

Phase I/II Trial Of Imatinib Mesylate; (Gleevec; STI571) In Treatment Of Recurrent Oligodendroglioma And Mixed Oligoastrocytoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Adult Anaplastic Oligodendroglioma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor

Thank you

Trial Information

Phase I/II Trial Of Imatinib Mesylate; (Gleevec; STI571) In Treatment Of Recurrent Oligodendroglioma And Mixed Oligoastrocytoma


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

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.


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

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.

Inclusion Criteria:

- Histologically confirmed oligodendroglioma or mixed oligoastrocytoma

- Grade 2-4

- Recurrent disease

- Patients with mixed gliomas must have > 25% oligodendrogliomatous component

- Failed prior surgery, radiotherapy, and temozolomide or nitrosourea-based therapy

- Progressive disease by MRI or CT scan

- Measurable or evaluable disease by MRI or CT scan

- More than 2 prior chemotherapy regimens for progressive or recurrent disease (pilot
study only)

- Currently taking anticonvulsants which can induce cytochrome p450 (e.g., phenytoin,
carbamazepine, barbiturates, or primidone (Phase I only)

- No prior or concurrent significant intratumoral hemorrhage

- Performance status - ECOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 3 times upper limit of normal

- Creatinine no greater than 2.0 mg/dL

- No myocardial infarction within the past 6 months

- No congestive heart failure requiring maintenance therapy for life-threatening
ventricular arrhythmias

- No New York Heart Association class III or IV heart disease

- No active uncontrolled infection

- No other severe concurrent disease that would preclude study or interfere
significantly with interpreting potential drug-induced toxic effects

- No other active malignancy except nonmelanoma skin cancer

- No concurrent serious immunocompromised status unless related to concurrent steroids

- HIV-positive patients allowed

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- At least 2 weeks since prior biologic noncytotoxic agents (e.g., thalidomide or

- No concurrent biologic therapy or immunotherapy for brain cancer

- No concurrent therapeutic warfarin or heparin

- Low-dose warfarin and heparin (1 mg daily) allowed

- No prior interstitial chemotherapy, including carmustine wafers, unless separate
lesion seen on MRI outside of prior treatment field

- At least 2 weeks since prior vincristine

- At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas)

- No concurrent chemotherapy for brain cancer

- At least 2 weeks since prior tamoxifen

- Concurrent corticosteroids allowed if dose stable for at least 1 week prior to study

- No concurrent hormonal therapy for brain cancer

- At least 12 weeks since prior radiotherapy

- No prior stereotactic radiosurgery or interstitial brachytherapy unless separate
lesion seen on MRI outside of prior treatment field

- No concurrent radiotherapy for brain cancer

- No other concurrent investigational or noninvestigational therapy for brain cancer

- At least 2 weeks since prior surgery for initial or progressive disease and recovered

- No concurrent surgery for brain cancer

- At least 2 weeks since prior isotretinoin

- At least 4 weeks since prior investigational agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

Up to 4 weeks

Safety Issue:


Principal Investigator

Kurt Jaeckle

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Adult Anaplastic Oligodendroglioma
  • Adult Mixed Glioma
  • Adult Oligodendroglioma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioma
  • Oligodendroglioma
  • Astrocytoma



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