Clinical trial NCT00597402 (phase 2, status: completed)
Conditions: glioblastoma, gliosarcoma, brain tumor
ICD codes: C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6
Drugs: avastin, temozolomide, irinotecan
SMILES: CSCC[C@H](N)C(O)=O, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed diagnosis of World Health Organization
             (WHO) grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma).
             Patients have to be within 4 weeks of the last major surgical procedure.

          -  Age > 18 years.

          -  An interval of at least 2 weeks and not > 6 weeks between prior major surgical
             procedure and study enrollment.

          -  No prior radiotherapy or chemotherapy for a brain tumor

          -  Karnofsky ≥ 60 percent.

          -  Hemoglobin ≥ 9.0 g/deciliter (dl), absolute neutrophil count (ANC) ≥ 1,500 cells/
             microliter, platelets ≥ 125,000 cells/microliter.

          -  Serum creatinine ≤ 1.5 mg/dl, serum serum glutamic-oxaloacetic transaminase (SGOT) and
             bilirubin ≤ 1.5 times upper limit of normal (ULN).

          -  For patients on corticosteroids, they must be on a stable or decreasing dose for 1
             week prior to entry, and the dose should not be escalated over entry dose level, if
             clinically possible.

          -  Signed informed consent approved by the Institutional Review Board

          -  No evidence of > grade 1 central nervous system (CNS) hemorrhage on the baseline MRI
             or CT scan.

          -  If sexually active, patients will take contraceptive measures for the duration of
             treatment as stated in the informed consent.

        Exclusion Criteria:

          -  Pregnancy or breast feeding.

          -  Co-medication that may interfere with study results; e.g. immuno-suppressive agents
             other than corticosteroids.

          -  Active infection requiring intravenous (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 on CT scan.

        Avastin-Specific Concerns:

        Subjects meeting any of the following criteria are ineligible for study entry:

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study

          -  Blood pressure of 150/100 mmHg

          -  Unstable angina

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure

          -  History of myocardial infarction within 6 months

          -  History of stroke within 6 months

          -  Clinically significant peripheral vascular disease

          -  Evidence of bleeding diathesis

          -  Coagulopathy (prothrombin time (PT) or partial thromboplastin time (PTT) >1.5x normal
             or a history of > three grade 2 or greater hemorrhages)

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to first Avastin infusion during XRT/Temodar or anticipation of need for major
             surgical procedure during the course of the study

          -  Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
             prior to first Avastin infusion during XRT/Temodar

          -  Pregnant (positive pregnancy test) or lactating

          -  Urine protein >1.0 + at screening

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to first Avastin infusion during XRT/Temodar

          -  Serious, non-healing wound, ulcer, or bone fractures.

          -  Inability to comply with study and/or follow-up procedures.