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A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors, Sarcoma

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Trial Information

A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas



- 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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the 6 month progression free survival

Outcome Description:

MRI will be done before treatment starts and then every 2 months while on study treatment to determine 6 month progression free survival

Outcome Time Frame:

MRI with MR Perfusion (optional) will be done before treatment and then every 2 months while on study treatment

Safety Issue:


Principal Investigator

Jeffrey J. Raizer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:

NU 05C4



Start Date:

May 2006

Completion Date:

April 2015

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Sarcoma
  • 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
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Sarcoma



Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Hematology-Oncology Associates of Illinois Chicago, Illinois  60611-2998