Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Eligibility Criteria

• * Histologically proven intracranial glioblastoma, with first or second recurrence
• * On stable or decreasing dose of steroids, if taken prior to screening
• * Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT
• * Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy
• * Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery
• * Life expectancy of more than three months
• * Karnofsky Performance Status of ≥ 70
• * Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication
• * Adequate bone marrow and organ function, confirmed by laboratory testing at screening
• * Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary
• * Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug
• * Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug
• * Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation
• * History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug
• * Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment
• * Prior therapy with fb-PMT or related drugs
• * Currently pregnant or breastfeeding
• * Active infection or serious intercurrent medical illness
• * Surgery of any type within the preceding 28 days that has not fully healed
• * A serious or non-healing wound, ulcer, or bone fracture
• * A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment
• * A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.
• * Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
• * Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
• * New York Heart Association classification of heart disease greater than Class 2
• * QTc interval \> 450 msec in males or \> 470 msec in females at screening
• * Use of concomitant medications that prolong the QT/QTc interval or risk inducing Torsades de Pointes
• * Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment
• * Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment
• * A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment
• * History of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months
• * History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)