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Imatinib Mesylate in Treating...

Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor

Last Updated: 2019-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2019-09-01

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. 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.

Conditions

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Adult Anaplastic Oligodendroglioma Adult Mixed Glioma Adult Oligodendroglioma Recurrent Adult Brain Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase II (Group 1)

Patients receive imatinib mesylate PO, at the MTD determined in phase I, BID for 4 weeks.

Group Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Optional correlative studies

Pharmacological Study

Intervention Type OTHER

Optional correlative studies

Phase II (Group 2)

Patients receive standard-dose imatinib mesylate PO BID for 4 weeks.

Group Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Optional correlative studies

Pharmacological Study

Intervention Type OTHER

Optional correlative studies

Interventions

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Imatinib Mesylate

Given PO

Intervention Type DRUG

Laboratory Biomarker Analysis

Optional correlative studies

Intervention Type OTHER

Pharmacological Study

Optional correlative studies

Intervention Type OTHER

Other Intervention Names

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CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt Jaeckle, MD

Role: STUDY_CHAIR

Mayo

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Bromenn Lifecare Center

Bloomington, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Site Status

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

Moline, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Sarah Culbertson Memorial Hospital

Rushville, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Site Status

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status

Saint Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Association

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status