Status:
TERMINATED
Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme
Lead Sponsor:
Thallion Pharmaceuticals
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00730262
Start Date
August 1 2008
End Date
June 1 2010
Last Update
December 30 2009
Active Locations (8)
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1
Sloan-Kettering Institute for Cancer Research
New York, New York, United States
2
Duke University
Durham, North Carolina, United States
3
Ottawa Health Research Institute
Ottawa, Ontario, Canada
4
The Pencer Brain Tumor Center, Princess Margaret Hospital
Toronto, Ontario, Canada