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

Stopped early · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT00730262

Run by

Thallion Pharmaceuticals

People needed

40

Starts

2008-08-01

Expected to finish

2010-06-01

Last updated by the study team

2009-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sloan-Kettering Institute for Cancer Research — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Ottawa Health Research Institute — Ottawa, Ontario, Canada
• The Pencer Brain Tumor Center, Princess Margaret Hospital — Toronto, Ontario, Canada
• Hôpital Notre-Dame du CHUM — Montreal, Quebec, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada
• L'Hotel-Dieu de Quebec — Québec, Quebec, Canada
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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