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

Status: Recruiting
Phase: Phase 2
Diagnosis: Sarcoma
NCT ID: NCT01661283 (View complete trial on
DFCI Protocol ID: 13-059


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


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Gregory Cote, MD, Massachusetts General Hospital

Site-responsible Investigators:
George Demetri, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Emily Leonard,
Dana-Farber Cancer Institute: Melissa Hohos,

Eligibility Criteria

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 - 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
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