Vatalanib in Treating Patients With Recurrent or Progressive Meningioma

NCT ID: NCT00348790

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2013-07-31

Brief Summary

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.

Detailed Description

OBJECTIVES:

Primary

• Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.

Secondary

• Determine the 6-month progression-free survival of these patients.
• Describe the response rate and overall survival of these patients.
• Determine the safety of vatalanib in these patients.
• Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
• Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.

OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

Brain and Central Nervous System Tumors; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vatalanib

Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.

Patients who are responding may remain on study treatment for 12 months.

Group Type: EXPERIMENTAL

vatalanib

Intervention Type: DRUG

Interventions

vatalanib

Intervention Type: DRUG

Other Intervention Names

PTK787; ZK 222584

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed meningioma, including the following subtypes:

• Benign meningioma
• Malignant meningioma

• Steroid dosage stable for ≥ 5 days
• Atypical meningiomas
• Hemangiopericytoma
• May or may not have neurofibromatosis (NF) type 1 or 2 disease

• Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been stable for the past 6 months
• Progressive or recurrent disease by MRI or CT scan

• Prior radiotherapy allowed provided evidence of disease progression is documented by positron emission tomography, thallium scanning, magnetic resonance spectroscopy, or surgery to rule out radiation necrosis for patients treated with radiosurgery
• Recent resection of recurrent or progressive tumor allowed provided both of the following criteria are met:

• At least 4 weeks since prior surgery and recovered
• Evaluable residual disease

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy > 12 weeks
• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL (transfusion allowed)
• SGOT and SGPT < 2 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine < 1.5 mg/dL
• Negative proteinuria dipstick OR total urinary protein ≤ 500 mg AND creatinine clearance ≥ 50 mL/min
• PT, INR, and PTT ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
• No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix, unless in complete remission and off all therapy for that disease for ≥ 3 years
• No disease that would obscure toxicity or dangerously alter drug metabolism
• No bleeding disorders
• No severe and/or uncontrolled medical conditions that would limit compliance with study requirements, including any of the following:

• Uncontrolled high blood pressure
• History of labile hypertension
• History of poor compliance with an antihypertensive regimen
• Unstable angina pectoris
• Symptomatic congestive heart failure
• Myocardial infarction within the past 6 months
• Serious uncontrolled cardiac arrhythmia
• Uncontrolled diabetes
• Active or uncontrolled infection
• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib (i.e., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets)
• QTc > 450 (male) or > 470 (female)
• Congenital or acquired long QTc syndrome

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior therapy
• At least 4 weeks since prior radiotherapy, including external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery
• At least 4 weeks since prior investigational agents
• More than 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)
• More than 4 weeks since prior immunotherapy
• More than 2 weeks since prior noncytotoxic or biologic therapies
• At least 2 weeks since prior drugs that affect hepatic metabolism (steroids should be tapered off if not clinically indicated)
• At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsant drugs
• No prior antivascular endothelial growth factor therapy
• No other concurrent investigational agents or anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy)
• No concurrent warfarin
• No concurrent grapefruit or grapefruit juice

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Raizer

Jeffrey Raizer, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey J. Raizer, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Hematology-Oncology Associates of Illinois

Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

STU00005338

Identifier Type: OTHER

Identifier Source: secondary_id

NU 05C4

Identifier Type: OTHER

Identifier Source: secondary_id

NU 05C4

Identifier Type: -

Identifier Source: org_study_id