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Vatalanib in Treating Patients With Recurrent or Progressive Meningioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348790
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : October 27, 2014
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):
Jeffrey Raizer, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Sarcoma Drug: vatalanib Phase 2

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
Study Start Date : May 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: 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.

Drug: vatalanib
Other Names:
  • PTK787
  • ZK 222584

Primary Outcome Measures :
  1. Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. [ Time Frame: From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment ]
    Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.

Secondary Outcome Measures :
  1. Determine Efficacy (Radiographic and Clinical Improvement) [ Time Frame: At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment ]
    Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment

  2. Best Overall Response Rate (ORR) [ Time Frame: Every 2 months for up to 1 year after study treatment. ]

    Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply.

    Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.

    Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.

    Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition

  3. To Correlate the Response Rates With Expression of Certain Types of Genes [ Time Frame: At the end of study treatment ]
    Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes

  4. Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas [ Time Frame: Every week while on study treatment until 30 days after last treatment. ]

    Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following:

    Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal

  5. Number of Months Patients Survive After Being Treatment on the Study. [ Time Frame: From the date the first patient began treatment until the date the last patient became deceased. ]
  6. Overall Survival (OS) [ Time Frame: Every 2 months for up to 1 year after study treatment. ]
    Overall Survival will be measured from the first treatment on study until death of any cause.

Other Outcome Measures:
  1. Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels [ Time Frame: MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment ]
    Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment

  2. To Use the FACT BR Questionnaire to Measure Quality of Life [ Time Frame: At baseline and then every time an MRI is performed while on study treatment. ]
    FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348790

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United States, Illinois
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Jeffrey J. Raizer, MD Northwestern University
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Responsible Party: Jeffrey Raizer, Jeffrey Raizer, MD, Northwestern University Identifier: NCT00348790    
Other Study ID Numbers: NU 05C4
STU00005338 ( Other Identifier: Northwestern University IRB )
NU 05C4 ( Other Identifier: Northwestern University )
First Posted: July 6, 2006    Key Record Dates
Results First Posted: October 27, 2014
Last Update Posted: October 26, 2018
Last Verified: October 2018
Keywords provided by Jeffrey Raizer, Northwestern University:
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
adult malignant hemangiopericytoma
adult anaplastic meningioma
adult papillary meningioma
adult melanocytic lesion
recurrent adult brain tumor
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action