Full Text View
Tabular View
No Study Results Posted
Related Studies
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
This study has been completed.
Study NCT00045734   Information provided by National Cancer Institute (NCI)
First Received: September 6, 2002   Last Updated: March 24, 2009   History of Changes

September 6, 2002
March 24, 2009
February 2003
November 2008   (final data collection date for primary outcome measure)
6-month progression-free survival [ Designated as safety issue: No ]
6-month progression-free survival
Complete list of historical versions of study NCT00045734 on ClinicalTrials.gov Archive Site
 
 
 
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma

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

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma.

OBJECTIVES:

  • Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.
  • Determine the response rate and overall survival of patients treated with this drug.
  • Evaluate the safety profile of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the surrogate endpoints of angiogenic activity of this drug in these patients.
  • 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.

Phase II
Interventional
Treatment, Open Label
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
 
Wen PY, Yung WK, Lamborn KR, Norden AD, Cloughesy TF, Abrey LE, Fine HA, Chang SM, Robins HI, Fink K, Deangelis LM, Mehta M, Di Tomaso E, Drappatz J, Kesari S, Ligon KL, Aldape K, Jain RK, Stiles CD, Egorin MJ, Prados MD. Phase II study of imatinib mesylate (Gleevec(R)) for recurrent meningiomas (North American Brain Tumor Consortium Study 01-08). Neuro Oncol. 2009 Mar 17; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
November 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks

Hematopoietic

  • 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

Hepatic

  • 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

Renal

  • Creatinine less than 1.5 mg/dL AND/OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

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

Pulmonary

  • No pulmonary embolism within the past 6 weeks

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 1 week since prior interferon or thalidomide
  • No concurrent immunotherapy
  • Concurrent epoetin alfa allowed

Chemotherapy

  • 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

Endocrine therapy

  • See Disease Characteristics
  • At least 1 week since prior tamoxifen
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00045734
 
CDR0000257267, NABTC-0108, NCI-03-C-0311
North American Brain Tumor Consortium
National Cancer Institute (NCI)
Study Chair: Patrick Y. Wen, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP