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Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, September 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Dana-Farber Cancer Institute
University of Virginia
University of Pittsburgh
Pfizer
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00589784
  Purpose

The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful.

Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.


Condition Intervention Phase
CNS Cancer
Meningioma
Intracranial Hemangiopericytoma
Hemangioblastoma
Neurofibromatosis
Drug: Sunitinib
Phase II

Genetics Home Reference related topics: familial encephalopathy with neuroserpin inclusion bodies neurofibromatosis type 1 neurofibromatosis type 2
MedlinePlus related topics: Cancer Neurofibromatosis
Drug Information available for: Sunitinib Sunitinib malate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To evaluate the activity of sunitinib in patients with recurrent meningiomas as measured by 6-month progression-free survival. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the response rate, median-time-to-progression and overall survival in this patient population; To evaluate the safety of sunitinib in patients with recurrent meningiomas. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment: Experimental
Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression.
Drug: Sunitinib

The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days. Patients on strong CYP3A4 inducers should start at a dose of 62.5 mg and those on strong CYP3A4 inhibitors should start at a dose of 37.5 mg. The dose should be taken once daily at approximately the same time each day.

Patients are required to have a drug rest period of at least 14 days after each dosing period. Dosing can be modified after discussion with the study investigator. The study investigator may implement dose suspension or reduction in order to ensure patient safety. Patients will be given a diary to take home to record their sunitinib dosing.


Detailed Description:

This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven recurrent meningioma or intracranial hemangiopericytoma or hemangioblastoma. This includes benign, atypical, or malignant meningioma; patients with neurofibromatosis type 1 or 2
  • Patients with classic radiographic picture of meningioma may also enroll if not surgically accessible
  • Unequivocal evidence for tumor progression by MRI
  • Steroids dosing - malignant meningiomas must be on stable dose for at least 5 days prior to baseline imaging.
  • Recent resection for recurrent tumor - patients will be eligible as long as they have recovered from the effects of surgery and have residual disease that can be evaluated.
  • Prior radiation therapy
  • Patients who have not had prior surgery or radiotherapy for their meningioma will be reviewed at multidisciplinary brain tumor conference including neurosurgery and radiation oncology to determine that the patient is appropriate for this study
  • Prior therapy: There is no limitation on the number of prior surgeries, radiation therapy, radiosurgery treatments, or chemotherapy.
  • All patients must sign an informed consent indicating that they are aware of the investigational nature of the study.
  • Age ≥ 18 years old
  • Karnofsky performance status ≥ 60%.
  • ≥ 4 weeks since prior RT, stereotactic radiosurgery, or chemotherapy.
  • Required Initial Laboratory Values
  • Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months.

Exclusion Criteria:

  • Patients with the history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years) are ineligible.
  • Any prior TKI therapy (SU011248, Sorafenib, Semaxinib, Axitinib)
  • Concomitant use of any other investigational drugs
  • Concomitant use of enzyme-inducing anti-epileptic drugs.
  • Concomitant use of St John's Wort.
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade ≥ 2.
  • Prolonged QTc interval on baseline EKG (>450 msec for males and >470 msec for females).
  • Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).
  • History of intracranial hemorrhage.
  • Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection.
  • Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
  • Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg daily for thromboembolic prophylaxis is allowed).
  • Pregnancy or breast-feeding. Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589784

Contacts
Contact: Lauren Abrey, MD abreyl@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lauren Abrey, MD         abreyl@mskcc.org    
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburg, Pennsylvania, United States
Contact: Frank Liberman, MD, PhD            
United States, Virginia
University of Virginia Health Science Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: David Schiff, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Dana-Farber Cancer Institute
University of Virginia
University of Pittsburgh
Pfizer
Investigators
Principal Investigator: Lauren Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Memorial Sloan-Kettering web site  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Lauren Abrey, MD )
Study ID Numbers: 07-135
Study First Received: December 26, 2007
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00589784  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Sunitinib
Brain Cancer
CNS Cancer
meningioma
intracranial hemangiopericytoma
hemangioblastoma
malignant meningioma
neurofibromatosis
neurofibromatosis type 1
neurofibromatosis type 2

Study placed in the following topic categories:
Meningeal Neoplasms
Central Nervous System Neoplasms
Neurodegenerative Diseases
Neurofibromatosis 1
Neurofibromatosis 2
Heredodegenerative Disorders, Nervous System
Neurofibroma
Neuromuscular Diseases
Sunitinib
Hemangioma
Meningioma
Nervous System Neoplasms
Neurocutaneous Syndromes
Hemangioblastoma
Hemangioma, Capillary
Hemangiopericytoma
Recurrence
Neurofibromatosis type 1
Neurofibromatosis type 2
Brain Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neurofibromatoses
Nerve Sheath Neoplasms

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Vascular Tissue
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009