Trial record 1 of 138 for:    "Meningioma"
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Imatinib Mesylate in Treating Patients With Recurrent Meningioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045734
First received: September 6, 2002
Last updated: June 11, 2013
Last verified: January 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival according to Response Evaluation Criteria In Solid Tumors Group (RECIST) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by the Cancer Therapy Evaluation program Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 5 years after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Tumor response as assessed by MRI and neurologic exam [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Surrogate markers of angiogenic peptides using functional neuro-imaging and in vitro bioassays [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Evidence of PDGF inhibition in tumor specimens [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
  • Correlation of genetic abnormalities with response to imatinib mesylate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2003
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

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

II. Determine the response rate and overall survival of patients treated with this drug.

III. Evaluate the safety profile of this drug in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine the surrogate endpoints of angiogenic activity of this drug in these patients.

VI. Correlate 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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)
  • SGOT less than 2 times ULN
  • PT, PTT, and 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045734

Locations
United States, Massachusetts
North American Brain Tumor Consortium
Watertown, Massachusetts, United States, 02472
Sponsors and Collaborators
Investigators
Principal Investigator: Patrick Wen North American Brain Tumor Consortium
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045734     History of Changes
Obsolete Identifiers: NCT00069667
Other Study ID Numbers: NCI-2012-02495, NABTC-0108, U01CA062399, CDR0000257267
Study First Received: September 6, 2002
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Meningioma
Brain Neoplasms
Hemangiopericytoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Meningeal Neoplasms
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014