Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme

Inclusion Criteria:

- Histologically confirmed Glioblastoma Multiforme (GBM)

- Prior treatment with radiation and one first line systemic therapy (including
temozolomide or other chemotherapy, immunotherapy, targeted therapy or combination
therapies), followed by measurable and unequivocal evidence of tumor progression or
recurrence

- Age ≥ 18 years

- ECOG ≤ 2

- Normal organ and marrow function as defined below:

- leukocytes ≥3 x 109/L

- absolute neutrophil count ≥1.5 x 109/L

- platelets ≥100 x 109/L

- hemoglobin ≥90 g/L

- total bilirubin ≤2.5 X institutional upper limit of normal

- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal

- creatinine ≤1.0 X institutional upper limit of normal

Exclusion Criteria:

- Patients with a life expectancy < 12 weeks

- Patients with a documented history of HIV, active hepatitis B or C infections

- Female patients who are pregnant or lactating

- Patients in whom a proper central line (Portacath-like device) cannot be established

- Patients with a known hypersensitivity to farnesylated dibenzodiazepinone or
polysorbate 80

- Patients with uncontrolled hypotension

- Patients with concomitant therapy of therapeutic coumadin