Clinical trial NCT00735436 (phase 2, status: terminated)
Conditions: malignant glioma, glioblastoma multiforme, gliosarcoma
ICD codes: R18.0, C17.3, G21.0, J91.0, C05.2, C10.0, C16.0, L51.0, L51.8, L51.9
Drugs: gliadel/avastin/cpt-11
SMILES: ClCCNC(=O)N(CCCl)N=O
Reason stopped: 
    study enrollment was halted due to slow accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed diagnosis of WHO grade IV primary
             malignant glioma (glioblastoma multiforme or gliosarcoma). Patients have to be able to
             undergo a GTR.

          -  Age > or = 18 years

          -  Evidence of a unilateral, single focus of measurable central nervous system (CNS)
             neoplasm on contrast-enhanced MRI, unless medically contraindicated (CT scan will then
             be used)

          -  Patients must have < or = 2 disease progressions

          -  An interval of at least 4 weeks from the end of prior radiotherapy or one week from
             the end of a cycle of chemotherapy and enrollment on this protocol

          -  Karnofsky > or = 70%

          -  Hemoglobin > or = 9.0 g/dl, absolute neutrophil count (ANC) > or = 1,500
             cells/microliters, platelets > or = 125,000 cells/microliters

          -  Serum creatinine < or = 1.5 mg/dl, serum glutamic-oxaloacetic transaminase (SGOT) and
             bilirubin < or = 1.5 times upper limit of normal

          -  Patients on corticosteroids must have been on a stable dose for 1 week prior to entry,
             if clinically possible, and the dose should not be escalated over entry dose level

          -  If patient received chemotherapy or investigational agent as part of their prior
             therapy, the patient must recover from all toxicities (> or = Grade 1) prior to
             enrollment on this protocol

          -  Signed informed consent approved by the Institutional Review Board

          -  No evidence of CNS hemorrhage on the baseline MRI or CT scans

          -  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. Women of childbearing potential must have a negative
             serum pregnancy test within 72 hours prior to treatment administration

          -  Multifocal disease

          -  Prior treatment with Gliadel

          -  Prior treatment with CPT-11 or Avastin

          -  Prior stereotactic radiosurgery or brachytherapy

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

          -  Active infection requiring IV antibiotics

          -  Acute or chronic renal insufficiency (a glomerular filtration rate (GFR) <30
             mL/min/1.73m2) or acute renal insufficiency of any severity due to hepato-renal
             syndrome or in the peri-operative liver transplantation period

          -  Inability, in the opinion of the study investigator, to comply with study and/or
             follow-up procedures

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored Avastin
             cancer study

          -  Life expectancy of less than 12 weeks

          -  Active malignancy, other than superficial basal cell and superficial squamous (skin)
             cell, or carcinoma in situ of the cervix within last five years

          -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
             diastolic blood pressure > 100 mmHg)

          -  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 Day 1

          -  History of stroke or transient ischemic attack within 6 months prior to Day 1

          -  Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
             recent peripheral arterial thrombosis) within 6 months prior to Day 1

          -  History of hemoptysis (> or = 1/2 teaspoon of bright red blood per episode) within 1
             month prior to Day 1

          -  Evidence of bleeding diathesis or significant coagulopathy (in the absence of
             therapeutic anticoagulation)

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 1 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 Day 1

          -  History of abdominal fistula, gastrointestinal perforation within 6 months prior to
             Day 1

          -  Serious, non-healing wound, active ulcer, or untreated bone fracture

          -  Proteinuria at screening as demonstrated by urinalysis (urine protein)

          -  Known hypersensitivity to any component of Avastin

          -  Pregnancy (positive pregnancy test) or lactation. Use of effective means of
             contraception (men and women) in subjects of child-bearing potential