Imatinib Mesylate in Treating Patients With Recurrent Meningioma

NCT00045734 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2012-02495NABTC-0108U01CA062399CDR0000257267
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

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

Conditions

Adult Grade I Meningioma; Adult Grade II Meningioma; Adult Grade III Meningioma; Adult Meningeal Hemangiopericytoma; Adult Meningioma; Recurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria

  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

  At 6 months

Secondary Outcomes (5)

• Progression-free Survival According to Response Evaluation Using Macdonald Criteria

  3 years

• 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

• Tumor Response as Assessed by MRI Using Macdonald Criteria

  Up to 5 years

• 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

• Determine Survival for Patients Treated With Imatinib Mesylate

  3 years

Other Outcomes (3)

• Determine Surrogate Markers of Angiogenic Peptides Using Functional Neuro-imaging and in Vitro Bioassays

  5 years

• Evidence of Platelet-derived Growth Factor (PDGF) Inhibition in Tumor Specimens

  - 3 years

• Determine Correlating Molecular Abnormalities in the Tumor With Response to Treatment

  3 years

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

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; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Treatment (imatinib mesylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (imatinib mesylate)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (imatinib mesylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (7)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

National Cancer Institute Neuro-Oncology Branch

Bethesda, Maryland, 20814, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Meningioma; Brain Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and 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.

Results Point of Contact

• Title: Patrick Wen, MD
• Organization: Adult Brain Tumor Consortium (ABTC)

jfisher@jhmi.edu

410-955-8837

Study Officials

• Patrick Wen, MD

  North American Brain Tumor Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)