SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors



Status:Completed
Conditions:Cancer, Other Indications, Neurology
Therapuetic Areas:Neurology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:September 2012
End Date:December 2017

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Phase 2 Study of the mTOR Inhibitor Everolimus in Combination With Bevacizumab in Patients With Sporadic and Neurofibromatosis Type 1 (NF1) Related Refractory Malignant Peripheral Nerve Sheath Tumors

To determine the clinical response rate of everolimus in combination with bevacizumab for
patients with chemotherapy refractory sporadic or neurofibromatosis type 1 (NF1) associated
malignant peripheral nerve sheath tumor (MPNST). To evaluate the toxicity and safety of
everolimus in combination with bevacizumab in individuals with MPNST


Inclusion Criteria:

- Patients 18 or older

- Unresectable or metastatic sporadic or NF1 associated high-grade MPNST

- Experienced progression after one or more prior regimens of cytotoxic chemotherapy

- Patients must be able to swallow tablets

- Patients must have measurable disease, defined as at least one tumor that is
measurable

- Patients who develop a recurrence or progression (WHO criteria) of an MPNST in a
previously radiated field may be enrolled if it has been at least 4 weeks since the
last dose of radiation therapy

- Patients must have recovered from the toxic effects of all prior therapy before
entering this study

- Adequate organ function

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Patents who received an anthracycline prior to enrollment must have an ejection
fraction ≥ 50%

- Subjects of childbearing potential requires acceptable form of birth control

- Informed consent

Exclusion Criteria:

- Patients currently receiving anticancer therapies or who have received anticancer
therapies within 3 weeks of the start of study drug or patients receiving prior
treatment with investigational drugs 4 weeks of the start of study drug

- Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have
received these medications within 1 week of entry

- Prior radiotherapy within 4 weeks of the start of study drug

- Patients who have had a major surgery or significant traumatic injury within 4 weeks
of start of study drug,

- Patients who have not recovered from the side effects of any major surgery

- Patients that may require major surgery during the course of the study

- Less than 7 days have passed from core biopsies or other minor surgical procedures
excluding placement of a vascular access device

- Patients receiving chronic, systemic treatment with corticosteroids or another
immunosuppressive agent(Topical or inhaled corticosteroids are allowed)

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases

- Other malignancies within the past 3 years except for adequately treated carcinoma of
the cervix or basal or squamous cell carcinomas of the skin

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study

- Female patients who are pregnant or breast feeding

- Patients who have received prior treatment with an mTOR inhibitor or bevacizumab

- Patients with known hypersensitivity to rapamycins

- concurrent use of anti-coagulant drugs

- Patients using Seville orange, star fruit, grapefruit and their juices, and St. John's
Wort

- Patients taking enzyme inducing anticonvulsants
We found this trial at
12
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Baltimore, MD
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Bethesda, Maryland
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Chicago, IL
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Philadelphia, Pennsylvania 19106
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Philadelphia, PA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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