Imatinib Mesylate in Treating Patients With Recurrent Meningioma

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00045734
• Collaborator: (none)
• Enrollment: 23
• Locations: 7
• Arm: 1
• Duration (Months): 82
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Condition or Disease	Intervention/Treatment	Phase
Adult Grade I Meningioma; Adult Grade II Meningioma; Adult Grade III Meningioma; Adult Meningeal Hemangiopericytoma; Adult Meningioma; Recurrent Adult Brain Tumor	Drug: imatinib mesylate; Other: laboratory biomarker analysis; Other: pharmacological study	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.

SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.

1. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.

2. Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs no).

Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 8-12 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (imatinib mesylate) Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis	Drug: imatinib mesylate; Given orally; Other Names: CGP 57148 Gleevec Glivec ; Other: laboratory biomarker analysis; Correlative studies; Other: pharmacological study; Correlative studies; Other Names: pharmacological studies

Outcome Measures

Primary Outcome Measures

1. 6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria [At 6 months]

   The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

Secondary Outcome Measures

1. Progression-free Survival According to Response Evaluation Using Macdonald Criteria [3 years]

   The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

2. Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0 [Up to 5 years after completion of study treatment]

   percentage of patients who had grade 3 or grade 4 adverse events

3. Tumor Response as Assessed by MRI Using Macdonald Criteria [Up to 5 years]

   The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

4. Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics) [pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9]

   Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1 result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8

5. Determine Survival for Patients Treated With Imatinib Mesylate [3 years]

   survival determined from start of treatment to date of death

Other Outcome Measures

1. Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays [5 years]

   Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.

2. Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens [- 3 years]

   insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue

3. Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment [3 years]

   Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed meningioma

• Benign, malignant, or atypical disease

• Neurofibromatosis (NF) type 1 or 2 allowed

• Hemangiopericytoma allowed

• Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)

• Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease

• Newly diagnosed recurrent disease that requires surgical debulking allowed

• Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy

• Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation

• Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months

• Performance status - Karnofsky 60-100%

• More than 8 weeks

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 120,000/mm^3

• Hemoglobin at least 10 g/dL (transfusions allowed)

• No bleeding disorders

• Bilirubin less than 2 times upper limit of normal (ULN)

• Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN

• Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN

• Creatinine less than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No deep venous or arterial thrombosis within the past 6 weeks

• No pulmonary embolism within the past 6 weeks

• No serious active infection

• No prior intracranial hemorrhage

• No concurrent disease that would obscure toxicity or dangerously alter drug metabolism

• No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years

• No other significant medical illness that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for 3 months after study participation

• At least 1 week since prior interferon or thalidomide

• No concurrent immunotherapy

• Concurrent epoetin alfa allowed

• At least 4 weeks since prior cytotoxic chemotherapy

• At least 2 weeks since prior vincristine

• At least 6 weeks since prior nitrosoureas

• At least 3 weeks since prior hydroxyurea or procarbazine

• No concurrent chemotherapy

• At least 1 week since prior tamoxifen

• No concurrent hormonal therapy

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

• Recovered from prior surgery

• Recovered from all prior therapy

• At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers

• At least 2 weeks since prior drugs that affect hepatic metabolism

• At least 4 weeks since prior investigational agents

• No concurrent warfarin (heparin or low-molecular weight heparin allowed)

• No other concurrent investigational agents

• No concurrent acetaminophen of more than 500 mg/day

• No other concurrent anticancer therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095
2	University of California San Francisco	San Francisco	California	United States	94115
3	National Cancer Institute Neuro-Oncology Branch	Bethesda	Maryland	United States	20814
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
6	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75235
7	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Patrick Wen, MD, North American Brain Tumor Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00045734
• Other Study ID Numbers: NCI-2012-02495; NABTC-0108; U01CA062399; CDR0000257267; NCT00069667
• First Posted: Jan 27, 2003
• Last Update Posted: May 15, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Meningioma; Hemangiopericytoma; Solitary Fibrous Tumors; Recurrence; Imatinib Mesylate

Study Results

Participant Flow

Recruitment Details	patients enrolled between June 2003 ad August 2005 in an outpatient clinic setting.

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Period Title: Overall Study
STARTED	23
COMPLETED	22
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Participants	23
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	13 56.5%
Male	10 43.5%
Karnofsky Performance Status Scale (KPS) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	80
Histology (participants) [Number]
Benign (WHO grade I)	13 56.5%
Atypical (WHO grade II)	5 21.7%
Anaplastic (WHO grade III)	5 21.7%
Prior Surgeries (surgeries) [Median (Full Range) ]
Median (Full Range) [surgeries]	3
Prior Radiation Therapies (Radiation Therapies) [Median (Full Range) ]
Median (Full Range) [Radiation Therapies]	1
Prior Chemotherapy Regimens (Chemotherapy Regimens) [Median (Full Range) ]
Median (Full Range) [Chemotherapy Regimens]	0

Outcome Measures

1. Primary Outcome

Title	6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria
Description	The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

Only 19 of the 23 patients were evaluable for response

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	19
Number [percentage of participants]	29.4 127.8%

2. Secondary Outcome

Title	Progression-free Survival According to Response Evaluation Using Macdonald Criteria
Description	The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Of the 22 eligible patients only 19 were evaluable for response

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	19
Median (Full Range) [months]	2

3. Secondary Outcome

Title	Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0
Description	percentage of patients who had grade 3 or grade 4 adverse events
Time Frame	Up to 5 years after completion of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	23
Number [percentage of patients]	2.3

4. Secondary Outcome

Title	Tumor Response as Assessed by MRI Using Macdonald Criteria
Description	The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

response at first scan

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	19
Progression	10 43.5%
Stable	9 39.1%

5. Secondary Outcome

Title	Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)
Description	Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1 result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8
Time Frame	pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9

Outcome Measure Data

Analysis Population Description

Only 14 samples available / evaluable for analysis

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	22
Day 8 Pre Dosing	2129 (1600)
Day 8 24 hour dosing	2248 (1408)

6. Secondary Outcome

Title	Determine Survival for Patients Treated With Imatinib Mesylate
Description	survival determined from start of treatment to date of death
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

death date of 7 patients were unknown at time of analysis

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	17
Median (Full Range) [months]	16.8

7. Other Pre-specified Outcome

Title	Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays
Description	Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due number of patients.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	0

8. Other Pre-specified Outcome

Title	Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens
Description	insufficient samples to allow Platelet-derived growth factor receptor (PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue
Time Frame	- 3 years

Outcome Measure Data

Analysis Population Description

insufficient samples to allow PDGFR-alpha and -beta expression to be correlated Of 22 patients only 7 samples available and only 5 yielded adequate tissue

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	0

9. Other Pre-specified Outcome

Title	Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment
Description	Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over Baseline (BL) if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Study terminated early, only 22 patients entered on study. Hence, this secondary outcome was never analyzed due to number of patients.

Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Measure Participants	0

Adverse Events

Time Frame	3 years
Arm/Group Title	Treatment (Imatinib Mesylate)
Arm/Group Description	Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis imatinib mesylate: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
All Cause Mortality
	Treatment (Imatinib Mesylate)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Imatinib Mesylate)
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Other (Not Including Serious) Adverse Events
	Treatment (Imatinib Mesylate)
	Affected / at Risk (%)	# Events
Total	10/22 (45.5%)
Blood and lymphatic system disorders
anemia	1/22 (4.5%)	1
Leukopenia	1/22 (4.5%)	1
Neutropenia	2/22 (9.1%)	2
Investigations
elevated serum glutamic pyruvic transaminase	1/22 (4.5%)	1
Metabolism and nutrition disorders
dehydrations	1/22 (4.5%)	1
Hypophosphatemia	2/22 (9.1%)	2
Nervous system disorders
CNS (intracranial) Hemorrhage	1/22 (4.5%)	1
dizziness	1/22 (4.5%)	1

Limitations/Caveats

The study was closed prematurely due to limited activity and slow accrual. Study was designed to enroll (statistically powered) for 30 patients into each group (30 benign; 30 Atypical and 30 Anaplastic) meningioma's. Study enroll only 23 patients.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.