Imatinib Mesylate in Treating Patients With Recurrent Meningioma

Recurrent Adult Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045734
• Other study ID #: NCI-2012-02495
• Secondary ID: NABTC-0108U01CA0
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2002
• Last updated: June 11, 2013
• Start date: February 2003

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00069667

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adult Grade I Meningioma
• Adult Grade II Meningioma
• Adult Grade III Meningioma
• Adult Meningeal Hemangiopericytoma
• Adult Meningioma
• Hemangiopericytoma
• Meningioma
• Recurrent Adult Brain Tumor
• Solitary Fibrous Tumors

Intervention

Drug:
• imatinib mesylate
Given orally

Other:
• laboratory biomarker analysis
Correlative studies
• pharmacological study
Correlative studies

Locations

Country	Name	City	State
United States	North American Brain Tumor Consortium	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival according to Response Evaluation Criteria In Solid Tumors Group (RECIST)		At 6 months	No
Secondary	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	Yes
Secondary	Tumor response as assessed by MRI and neurologic exam		Up to 5 years	No
Secondary	Survival		Up to 5 years	No
Secondary	Surrogate markers of angiogenic peptides using functional neuro-imaging and in vitro bioassays		Up to 5 years	No
Secondary	Evidence of PDGF inhibition in tumor specimens		At the time of surgery	No
Secondary	Correlation of genetic abnormalities with response to imatinib mesylate		Up to 5 years	No