Status:
TERMINATED
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
Eisai Inc.
Conditions:
Glioblastoma Multiforme
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combinatio...
Eligibility Criteria
Inclusion
- 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
- Karnofsky \> 60%
- Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 cells/microliters, platelets ≥ 125,000 cells/microliters
- 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.
Exclusion
- 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
- Avastin-Specific
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01186406
Start Date
April 1 2011
End Date
June 16 2014
Last Update
February 15 2019
Active Locations (1)
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1
The Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, United States, 27710