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

A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme

The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line systemic therapy post surgery/radiotherapy.

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