Vatalanib in Treating Patients With Recurrent or Progressive Meningioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Jeffrey Raizer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00348790
First received: July 5, 2006
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Sarcoma
Drug: vatalanib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To determine the 6 month progression free survival [ Time Frame: MRI with MR Perfusion (optional) will be done before treatment and then every 2 months while on study treatment ] [ Designated as safety issue: No ]
    MRI will be done before treatment starts and then every 2 months while on study treatment to determine 6 month progression free survival


Secondary Outcome Measures:
  • Determine Efficacy (radiographic and clinical improvement) [ Time Frame: At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment ] [ Designated as safety issue: No ]
    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

  • To describe the response rate and overall survival in this patient population [ Time Frame: Every 2 months for up to 1 year after study treatment ] [ Designated as safety issue: No ]
    Response rate and overall survival will be assessed by MRI scan every 2 months while on study treatment and follow-up will be done at regularly scheduled office visits up to 1 year after discontinuation of study treatment.

  • To correlate the response rates with expression of certain types of genes [ Time Frame: At the end of study treatment ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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

  • To determine the safety of vatalanib in patients with recurrent of progressive meningiomas [ Time Frame: Every week while on study treatment ] [ Designated as safety issue: Yes ]
    Safety of vatalanib will be assessed by labs being done weekly


Enrollment: 25
Study Start Date: May 2006
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
vatalanib
Drug: vatalanib
Patients will be given 500 mg twice a day (4 tablets) of PTK-787 daily for 28 days (1 cycle) by mouth. 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.
Other Names:
  • PTK787
  • ZK 222584

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348790

Locations
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, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45219
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Northwestern University
Novartis
Investigators
Principal Investigator: Jeffrey J. Raizer, MD Northwestern University
  More Information

No publications provided

Responsible Party: Jeffrey Raizer, Jeffrey Raizer, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00348790     History of Changes
Other Study ID Numbers: NU 05C4, STU00005338, NU 05C4
Study First Received: July 5, 2006
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by 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:
Meningioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Sarcoma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Connective and Soft Tissue
Vatalanib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014