Patient case: 70-year-old male with melanoma; genetic feature: NF1 truncation

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

Summary: 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


Eligibility: 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

Relevance to patient case: not relevant