Clinical Trials /

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

NCT01661283

Description:

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

Related Conditions:
  • Malignant Peripheral Nerve Sheath Tumor
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Everolimus</span> With <span class="go-doc-concept go-doc-intervention">Bevacizumab</span> to Treat Refractory Malignant Peripheral Nerve Sheath Tumors

Title

  • Brief Title: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors
  • Official Title: 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
  • Clinical Trial IDs

    NCT ID: NCT01661283

    ORG ID: SARC016

    Trial Conditions

    Malignant Peripheral Nerve Sheath Tumors

    MPNST

    Sarcoma

    Trial Interventions

    Drug Synonyms Arms
    everolimus Afinitor, everolimus Arm A
    bevacizumab Avastin Arm A

    Trial Purpose

    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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A Experimental All patients with MPNST will continue everolimus 10 mg daily and bevacizumab 10 mg/kg dose every 14 days everolimus, bevacizumab

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Evaluation of lesions for progression or response via Who criteria

    Secondary Outcome Measures

    Trial Keywords

    MPNST

    malignant peripheral nerve sheath tumors

    RAD001

    Everolimus

    Bevacizumab

    Sarcoma

    Avastin

    mTOR inhibitor