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Title:
A 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
Protocol Number:
J12111
Phase:
Phase II
Physician:
Christian Meyer
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
Eligibility:
Male or female ages 18 (included) years and older on day of signing consent are eligible. Patients who have been diagnosed with unresectable or metastatic MPNST, no matter if they have NF1 or not, and their cancer has progressed after receiving at least one prior regimen of chemotherapy will be eligible. Patient must be up and out of bed more than 50% of the day and have good organ function and blood counts. Patients must have measurable disease by CT scan or MRI. Patients with reoccurrence of MPNST who have previously radiated can be enrolled if it has been at least 4 weeks since the last dose of radiation therapy. Patients must be able to swallow the pills.Patients with childbearing age must be on birth control pills.
Treatment:
After consent and review/confirmation of patient�s eligibility, patient will initiate treatment on the study. Patients will receive 28 day cycles of everolimus + bevacizumab until disease progression or unacceptable toxicity for a maximum of 2 years. Everolimus is administered orally once daily on a continuous dosing schedule, Bevacizumab is administered as an intravenous infusion every two weeks. Frequent visits to clinic for blood work, doctor/nurse visits, and tests are required. Patient will have CT scan done approximately every 8 weeks to determine response. Tumor samples and blood samples may also be collected in patients with NF1 type MPNST. Strict adherence and compliance to study schedule is required
Population:
Adult
Last Update
08/20/2014 04:02 AM
 

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