Brief 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. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jun 2003

Longer than P75 for phase_1

Geographic Reach

1 country

229 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

16.3 years study duration

First Submitted

Initial submission to the registry

November 12, 2002

Completed

3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

4 months until next milestone

Study Start

First participant enrolled

June 1, 2003

Completed

8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed

4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed

Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

8.2 years

First QC Date

November 12, 2002

Results QC Date

November 25, 2013

Last Update Submit

October 4, 2019

Conditions

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

Outcome Measures

Primary Outcomes (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.
6 months

Secondary Outcomes (3)

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).
Up to 5 years
Percentage of Patients Progression-free
Time from study registration to date of disease progression or last follow-up, assessed up to 5 years
Overall Time to Death
Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years

Study Arms (2)

Phase II (Group 1)

EXPERIMENTAL

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

Drug: Imatinib MesylateOther: Laboratory Biomarker AnalysisOther: Pharmacological Study

Phase II (Group 2)

EXPERIMENTAL

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

Drug: Imatinib MesylateOther: Laboratory Biomarker AnalysisOther: Pharmacological Study

Interventions

Imatinib MesylateDRUG

Given PO

Also known as: CGP 57148, CGP57148B, Gleevec, Glivec, STI 571, STI-571, STI571

Phase II (Group 1)Phase II (Group 2)

Laboratory Biomarker AnalysisOTHER

Optional correlative studies

Phase II (Group 1)Phase II (Group 2)

Pharmacological StudyOTHER

Optional correlative studies

Phase II (Group 1)Phase II (Group 2)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+14 more criteria

You may not qualify if:

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)
Significant intratumoral hemorrhage on baseline MRI or CT, or other history of significant intratumoral hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (229)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Bromenn Lifecare Center

Bloomington, Illinois, 61701, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)