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Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma

Phase 2
18 Years
Not Enrolling
Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Adult Meningeal Hemangiopericytoma, Adult Meningioma, Recurrent Adult Brain Tumor

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Trial Information

Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma


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

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival according to Response Evaluation Criteria In Solid Tumors Group (RECIST)

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

Patrick Wen

Investigator Role:

Principal Investigator

Investigator Affiliation:

North American Brain Tumor Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Adult Grade I Meningioma
  • Adult Grade II Meningioma
  • Adult Grade III Meningioma
  • Adult Meningeal Hemangiopericytoma
  • Adult Meningioma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Hemangiopericytoma
  • Meningioma



North American Brain Tumor Consortium Watertown, Massachusetts  02472