Clinical Trial Finder

Inclusion 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.

Exclusion Criteria:

• - 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)

Arms

Experimental: Treatment (fb-PMT)

Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.

Interventions

Drug: - fb-PMT

Daily dosing based on patient weight