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

Completed · Phase 2

Conditions studied: Malignant Peripheral Nerve Sheath Tumors, MPNST, Sarcoma

In brief

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

Key facts

Study ID

NCT01661283

Run by

Sarcoma Alliance for Research through Collaboration

People needed

25

Starts

2012-09-01

Expected to finish

2017-12-01

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Ann and Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins — Baltimore, Maryland, United States
• National Cancer Institute — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Pennsylvania Oncology Hematology Associates — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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