Clinical trial NCT02348255 (phase 2, status: withdrawn)
Conditions: adult brain glioblastoma, recurrent adult brain neoplasm
ICD codes: C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6
Drugs: carmustine
SMILES: ClCCNC(=O)N(CCCl)N=O
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed GBM

          -  Progressive disease after temozolomide and radiation therapy (in "first relapse")

          -  At least 28 days since chemotherapy or radiation

          -  Karnofsky performance score at least 70%

          -  Platelet count >= 130/mm^3

          -  Absolute neutrophil count >= 1500/mm^3

          -  Calculated creatinine clearance greater than 45 mg/dl using the Cockcroft-Gault
             formula

          -  Aspartate aminotransferase (AST) < 2 times the upper limit of normal

          -  Bilirubin < 1.5 times the upper limit of normal

          -  Subjects with child-bearing potential agree to use effective means of contraception

        Exclusion Criteria:

          -  Prior systemically administered nitrosoureas or vascular endothelial growth factor
             (VEGF) targeted therapy

          -  Chemotherapy for glioma other than temozolomide or Gliadel wafers (steroids are
             allowed)

          -  Pregnant or breast feeding

          -  Active inflammatory bowel disease

          -  Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess
             within 6 months

          -  Hypertension: systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) >
             100 mm mercury (Hg) despite antihypertensive medications

          -  New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF);
             myocardial infarction or unstable angina within 6 months

          -  History of thrombosis

          -  Symptomatic peripheral vascular disease, stroke or transient ischemic attack within 6
             months

          -  Bleeding risks: Required to be on therapeutic anticoagulation (aspirin is allowed),
             coagulopathy (e.g. hemophilia or von Willebrand's disease); any grade III or greater
             hemorrhage, major surgical procedure, or significant trauma within 28 days; core
             biopsy or other minor surgical procedure, excluding placement of a vascular access
             device, within 7 days

          -  Activated partial thromboplastin time (APTT) must not exceed 32.5 seconds (normal
             range 21.8-31.5 seconds); international normalized ratio (INR) must not exceed 1.30
             (normal range 0.87-1.18)

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

          -  Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators,
             vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts), a skull
             defect (such as missing bone with no replacement), a shunt, or bullet fragments

          -  Known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG)
             stickers or transcutaneous electrical nerve stimulation (TENS) electrodes

          -  Human immunodeficiency virus (HIV) positive

          -  Proteinuria at screening as demonstrated by urine dipstick >= 2+

          -  Prior organ transplantation

          -  Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
             human antibodies

          -  Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel or any other drug
             whose goal is to inhibit platelet function

          -  Unable to give signed informed consent