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Sunitinib in Treating Patients With Recurrent or Unresectable Meningioma, Intracranial Hemangiopericytoma, or Intracranial Hemangioblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on November 20, 2007.   Last Updated on July 28, 2010   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00561665
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying sunitinib to see how well it works in treating patients with recurrent or unresectable meningioma, intracranial hemangiopericytoma, or intracranial hemangioblastoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Neurofibromatosis Type 1
Neurofibromatosis Type 2
Precancerous Condition
Drug: sunitinib malate
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Correlation of response to the molecular phenotype of the tumor [ Designated as safety issue: No ]
  • Correlation of serum angiogenic peptides, circulating endothelial cells (CEC) and circulating progenitor cells (CEP), and Dynamic Contrast Enhanced (DCE)-MRI with outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the activity of sunitinib malate in patients with recurrent meningioma as measured by 6-month progression-free survival.

Secondary

  • To describe the response rate, median time-to-progression, and overall survival in these patient.
  • To evaluate the safety of sunitinib malate in patients with recurrent meningioma.

Exploratory

  • To develop exploratory data correlating response to the molecular phenotype of the tumor.
  • To develop exploratory data correlating serum angiogenic peptides, circulating endothelial cells (CEC) and circulating progenitor cells (CEP), and Dynamic Contrast Enhanced (DCE)-MRI with outcomes.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (benign vs malignant) and whether or not they have neurofibromatosis type 2 (yes vs no).

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then periodically thereafter.

PROJECTED ACCRUAL: A total of 50 patients (40 patients with meningioma and 10 patients with hemangiopericytomas/hemangioblastomas) 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 or intracranial hemangiopericytoma or hemangioblastoma

    • Recurrent or unresectable disease
    • Benign, atypical, or malignant meningioma
    • Neurofibromatosis (NF) type 1 or type 2 allowed
  • Classic radiographic picture of meningioma allowed provided the tumor is not surgically accessible

    • Must undergo review at a multidisciplinary brain tumor conference including neurosurgery and neuroradiology to determine that the patient is appropriate for this study
  • Unequivocal evidence of tumor progression by MRI or CT scan
  • Patients with malignant meningioma must be on a stable dose of steroids for at least 5 days prior to baseline imaging

    • Patients with benign or atypical meningioma are not required to be on a stable dose of steroids
  • Patients who have not had prior surgery or radiotherapy for meningioma will be reviewed at a multidisciplinary brain tumor conference including neurosurgery and radiation oncology to determine that the patient is appropriate for this study
  • Patients with a history of NF may have other stable CNS tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Karnofsky performance status ≥ 60%
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 x upper limit of normal (ULN)
  • Serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x ULN
  • Creatinine ≤ 2.0 mg/dL
  • PT, INR, and PTT ≤ 1.5 x ULN
  • Total serum bilirubin ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women must be surgically sterile, postmenopausal, or agree to use effective contraception during study therapy and men must be surgically sterile or agree to use effective contraception
  • Patients who have not had prior surgery or radiotherapy for their meningioma will be reviewed at a multidisciplinary brain tumor conference including neurosurgery and radiation oncology to determine that the patient is appropriate for this study

Exclusion criteria:

  • 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 the disease for a minimum of 3 years
  • Any of the following within the past 6 months:

    • Myocardial infarction
    • Severe/unstable angina
    • Coronary/peripheral artery bypass graft
    • Symptomatic congestive heart failure
    • Cerebrovascular accident or transient ischemic attack
    • Pulmonary embolism
  • Ongoing cardiac dysrhythmias ≥ grade 2 by NCI CTCAE Version 3.0
  • Prolonged QTc interval on baseline EKG (> 450 msec for males or > 470 msec for females)
  • Uncontrolled hypertension (> 150/100 mm Hg despite optimal medical therapy), elevated diastolic blood pressure (BP), systolic BP or both
  • 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), acquired immunodeficiency syndrome (AIDS)-related illness, or other active infection

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • At least 4 weeks since prior standard external beam radiotherapy , interstitial brachytherapy, or radiosurgery in any combination and there must be subsequent evidence of tumor progression

    • Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR spectroscopy, or surgical documentation of disease
  • At least 4 weeks since prior radiotherapy, radiosurgery, or chemotherapy

    • There is no limitation on the number of prior surgeries, radiotherapy, radiosurgery treatments, or chemotherapy
  • Recent resection for recurrent tumor allowed provide the patient has recovered from the effects of surgery and has residual disease that can be evaluated

    • CT scan/MRI should be done no later than 96 hours in the immediate postoperative period or at least 4 weeks post-operatively

      • If the 96 hour scan is more than 14 days before registration, it should be repeated
    • Must wait at least 14 days after surgery, without complications, before start of study treatment

Exclusion criteria:

  • Any prior tyrosine kinase inhibitor therapy (i.e., SU011248, sorafenib, semaxinib, or axitinib)
  • Any other concurrent investigational drugs
  • Concurrent enzyme-inducing antiepileptic drugs
  • Concurrent St. John's wort
  • Concurrent treatment on another clinical trial except supportive care trials or non-treatment trials (e.g., quality of life studies)
  • Concurrent therapeutic doses of warfarin

    • Concurrent low dose warfarin (≤ 2 mg/day) for thromboembolic prophylaxis is allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561665

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Patrick Y. Wen, MD     617-632-2166     patrick_wen@dfci.harvard.edu    
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lauren E. Abrey, MD     212-639-5122     abreyl@mskcc.org    
United States, Pennsylvania
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers     412-647-8073        
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908-0432
Contact: David Schiff, MD     434-982-4415        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Andrew B. Lassman, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Lauren E. Abrey, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00561665     History of Changes
Other Study ID Numbers: CDR0000574581, MSKCC-07135, 07-135, PFIZER-MSKCC-07135
Study First Received: November 20, 2007
Last Updated: July 28, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult meningioma
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma
recurrent adult brain tumor
adult meningeal hemangiopericytoma
neurofibromatosis type 1
neurofibromatosis type 2
precancerous condition

Additional relevant MeSH terms:
Disease
Hemangiopericytoma
Meningioma
Nervous System Neoplasms
Neurofibromatosis 1
Osteitis Fibrosa Cystica
Neurofibromatosis 2
Precancerous Conditions
Neurofibromatoses
Central Nervous System Neoplasms
Hemangioblastoma
Pathologic Processes
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurofibroma
Nerve Sheath Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Bone Diseases

ClinicalTrials.gov processed this record on February 12, 2012