AzTrials
AzTrials

Adult Anaplastic OligodendrogliomaPhase 1/2NCT00049127

Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor

A Phase 1/2 study testing Imatinib Mesylate, Laboratory Biomarker Analysis and Pharmacological Study in people with Adult Anaplastic Oligodendroglioma and Adult Mixed Glioma, run by Alliance for Clinical Trials in Oncology at 229 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Imatinib Mesylate, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
229 sitesUnited States
Study dates
Jun 2003to 1 Sep 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

229 sites in 1 country.

229 sites in 1 country

United States229 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Medini, Eitan MD (UIA Investigator)

    Alexandria, Minnesota, 56308

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium CCOP

    Ann Arbor, Michigan, 48106

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Memorial Hospital of Arkansas City

    Arkansas City, Kansas, 67005

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • Deaconess Medical Center

    Billings, Montana, 59107

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Bromenn Lifecare Center

    Bloomington, Illinois, 61701

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine of Bozeman

    Bozeman, Montana, 59715

  • Brainerd Medical Center Inc

    Brainerd, Minnesota, 56401

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Medical Center Clinic-Butler Office

    Butler, Pennsylvania, 16001

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Etzell, Paul S MD (UIA Investigator)

    Fergus Falls, Minnesota, 56537

  • Swenson, Wade II, MD (UIA Investigator)

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Fremont Area Medical Center

    Fremont, Nebraska, 68025

  • Fremont Memorial Hospital

    Fremont, Ohio, 43420

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Sharon Regional Cancer Center

    Hermitage, Pennsylvania, 16148

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Allegiance Health

    Jackson, Michigan, 49201

  • Center for Hematology- Oncology of Southern Michigan PLC

    Jackson, Michigan, 49201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Cole, Sharon, K. M.D. (UIA Investigator)

    Kenton, Ohio, 43326

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67901

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Bryan LGH Medical Center West

    Lincoln, Nebraska, 68502

  • Bryan LGH Medical Center East

    Lincoln, Nebraska, 68506

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Community Memorial Hospital

    Missouri Valley, Iowa, 51555

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Vigliotti, Antonio, P.G. M.D. (UIA Investigator)

    Moline, Illinois, 61265

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota, 56265

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Burgess Memorial Hospital

    Onawa, Iowa, 51040

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers-Oregon

    Oregon, Ohio, 43616

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Cancer Center of Kansas - Ottawa

    Ottawa, Kansas, 66067

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Medical Center Clinic-Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sarah Culbertson Memorial Hospital

    Rushville, Illinois, 62681

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Metro-Minnesota NCI Community Oncology Research Program

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Saint Joseph's Hospital - Healtheast

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Adult and Pediatric Urology PLLP

    Sartell, Minnesota, 56377

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford NCI Community Oncology Research Program of the North Central Plains

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Mercy Saint Anne Hospital

    Toledo, Ohio, 43623

  • Stark, Michael, Edward. M.D. (UIA Investigator)

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita CCOP

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Cancer Consortium-Upstate NCORP

    Winston-Salem, North Carolina, 27104

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Woodwinds Health Campus

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Phase I/II Trial of Imatinib Mesylate; (Gleevec; STI571) in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Imatinib Mesylate, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings
Oligodendroglioma, Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib MesylateDrug

    Also called CGP 57148, CGP57148B, Gleevec, Glivec

    Given PO

  • Laboratory Biomarker AnalysisOther

    Optional correlative studies

  • Pharmacological StudyOther

    Optional correlative studies

Study groups in NCT00049127
Study groupRoleWhat they receive
Phase II (Group 1)ExperimentalPatients receive imatinib mesylate PO, at the MTD determined in phase I, BID for 4 weeks.
Receives: Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Phase II (Group 2)ExperimentalPatients receive standard-dose imatinib mesylate PO BID for 4 weeks.
Receives: Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.

    The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm.

    Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

    Measured: 6 months

Secondary outcomes (3)

  1. Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).

    Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance.

    Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.

    Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.

    Measured: Up to 5 years

  2. Percentage of Patients Progression-free

    The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions.

    Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

    Measured: Time from study registration to date of disease progression or last follow-up, assessed up to 5 years

  3. Overall Time to Death

    Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.

    Measured: Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionAug 2011
  4. Study completion1 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049127
Sponsor's protocol ID
N0272
Other IDs
NCI-2011-01576, NCCTG-N0272, CDR0000257812, U10CA025224
Status last verified
Oct 2019
First submitted
12 Nov 2002
Last updated
21 Oct 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Imatinib Mesylate, Laboratory Biomarker Analysis and Pharmacological Study in people with Adult Anaplastic Oligodendroglioma and Adult Mixed Glioma, run by Alliance for Clinical Trials in Oncology at 229 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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