Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
Genentech, Inc.
Eisai Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have a MRI consistent with a WHO grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma), and be candidates for surgical resection with Gliadel wafer placement. Patients have to be within 6 weeks of the last major surgical procedure.
Age ≥ 18 years
Candidates for Gliadel
If a prior procedure was done, an interval of at least 2 weeks and not \> 8 weeks between prior major surgical procedure and study enrollment
No prior radiotherapy or chemotherapy for a brain tumor
Serum creatinine ≤ 1.5 mg/dl, serum SGOT and bilirubin ≤ 1.5 times upper limit of normal.
Signed informed consent approved by the Institutional Review Board
If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 6 months afterwards as stated in the informed consent.
You may not be if
Pregnancy or breast feeding.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
Active infection requiring IV antibiotics.
Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor.
Evidence of \> grade 1 CNS hemorrhage on baseline MRI or CT scan.
Prior treatment with Avastin for any condition
Prior, unrelated malignancy requiring active treatment with the exception cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
Prior history of hypertensive crisis or hypertensive encephalopathy
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infarction or unstable angina within 6 months prior to study enrollment
History of stroke or transient ischemic attack within 6 months prior to study enrollment
Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrollment
History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month prior to study enrollment
Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first Avastin infusion or anticipation of need for major surgical procedure during the course of the study
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
History of abdominal fistula, gastrointestinal perforation within 6 months prior to study enrollment
Serious, non-healing wound, active ulcer, or untreated bone fracture
Proteinuria at screening as demonstrated by urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
Known hypersensitivity to any component of Avastin
Pregnant (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential
Clareo Health | Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)
