Know Cancer

or
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
N/A
Open (Enrolling)
Both
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


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.


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
participation

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

- 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
entry

- 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:

Interventional

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:

Yes

Principal Investigator

Kurt Jaeckle

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01576

NCT ID:

NCT00049127

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

Name

Location

Mayo ClinicRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Via Christi Regional Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Great Falls ClinicGreat Falls, Montana  59405
Mount Sinai Medical CenterNew York, New York  10029
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Welch Cancer CenterSheridan, Wyoming  82801
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Valley Cancer CenterSpring Valley, Illinois  61362
Community Cancer Center of MonroeMonroe, Michigan  48162
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Bryan LGH Medical Center WestLincoln, Nebraska  68502
Bismarck Cancer CenterBismarck, North Dakota  58501
Wood County Oncology CenterBowling Green, Ohio  43402
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Eureka HospitalEureka, Illinois  61530
Cancer Center of Kansas - OttawaOttawa, Kansas  66067
Mercy HospitalCoon Rapids, Minnesota  55433
BroMenn Lifecare CenterBloomington, Illinois  61701-3081
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Saint Anthony Regional HospitalCarroll, Iowa  51401
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Community Memorial HospitalMissouri Valley, Iowa  51555-1199
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Fremont Area Medical CenterFremont, Nebraska  68025-2387
Bryan LGH Medical Center EastLincoln, Nebraska  68506
Saint Luke's HospitalMaumee, Ohio  43537
Geisinger Medical GroupState College, Pennsylvania  16801
Alegent Health Mercy HospitalCouncil Bluffs, Iowa  51503
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Fisher-Titus Medical CenterNorwalk, Ohio  44857
Rocky Mountain OncologyCasper, Wyoming  82609
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Guardian Oncology and Center for WellnessMissoula, Montana  59804
University of VirginiaCharlottesville, Virginia  22908
Woodwinds Health CampusWoodbury, Minnesota  55125
Hennepin County Medical CenterMinneapolis, Minnesota  
Toledo ClinicOregon, Ohio  43616
Mid Dakota ClinicBismarck, North Dakota  58501
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Flower HospitalSylvania, Ohio  43560-2197
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Oncology AssociatesCedar Rapids, Iowa  52403
Montana Cancer SpecialistsMissoula, Montana  59807-7877
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Joliet Oncology-Hematology Associates LimitedJoliet, 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 FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Sarah Culbertson Memorial HospitalRushville, Illinois  62681
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Clinic-Urbana MainUrbana, Illinois  61801
Constantinou, Costas L MD (UIA Investigator)Bettendorf, Iowa  52722
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Saint Luke's HospitalCedar Rapids, Iowa  52402
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Burgess Memorial HospitalOnawa, Iowa  51040
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Siouxland Hematology - Oncology AssociatesSioux City, Iowa  51101
Memorial Hospital of Arkansas CityArkansas City, Kansas  67005
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Brainerd Medical Center IncBrainerd, Minnesota  56401
Saint Joseph's Medical CenterBrainerd, Minnesota  56401
Saint Mary's Medical CenterDuluth, Minnesota  55805
Miller-Dwan HospitalDuluth, Minnesota  55805
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Saint Joseph's Hospital - HealtheastSaint Paul, Minnesota  55102
Adult and Pediatric Urology PLLPSartell, Minnesota  56377
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Deaconess Medical CenterBillings, Montana  59107
Billings ClinicBillings, Montana  59107-7000
Internal Medicine of BozemanBozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Saint Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Lincoln Medical Education Foundation Cancer Resource CenterLincoln, Nebraska  68510
Midlands Community HospitalPapillion, Nebraska  68046
Saint Alexius Medical CenterBismarck, North Dakota  58501
Medcenter One Health SystemsBismarck, North Dakota  58501
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Blanchard Valley HospitalFindlay, Ohio  45840
Cole, Sharon, K. M.D. (UIA Investigator)Kenton, Ohio  43326
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
The Toledo HospitalToledo, Ohio  43606
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Geisinger Wyoming ValleyWilkes-Barre, Pennsylvania  18711
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
North Coast Cancer Care-ClydeClyde, Ohio  43410
Community Health Partners Regional Medical CenterElyria, Ohio  44035
Stark, Michael, Edward. M.D. (UIA Investigator)Toledo, Ohio  43623
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Center for Hematology- Oncology of Southern Michigan PLCJackson, Michigan  49201
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Medical Center Clinic-Butler OfficeButler, Pennsylvania  16001
Geisinger Medical Center-Cancer Center HazeltonHazleton, Pennsylvania  18201
Sharon Regional Cancer CenterHermitage, Pennsylvania  16148
Medical Center Clinic-Allegheny General HospitalPittsburgh, Pennsylvania  15212