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Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: Robert H. Lurie Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00348790
  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 II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Vatalanib Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy (radiographic and clinical improvement) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: May 2006
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348790

Locations
United States, Illinois
Hematology-Oncology Associates of Illinois Recruiting
Chicago, Illinois, United States, 60611-2998
Contact: Steven B. Newman, MD     312-664-5400     steven.newman@usoncology.com    
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Jeffrey J. Raizer )
Study ID Numbers: CDR0000486746, NU-05C4, NU-1398-025, NOVARTIS-NU-05C4
Study First Received: July 5, 2006
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00348790  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Brain Neoplasms
Meningeal Neoplasms
Malignant mesenchymal tumor
Sarcoma
Meningioma
Central Nervous System Neoplasms
Hemangiopericytoma
Soft tissue sarcomas
Recurrence
Nervous System Neoplasms
Vatalanib

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009