Glioblastoma Multiforme Clinical Trial
Official title:
A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
Verified date | December 2009 |
Source | Thallion Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | June 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hôpital Notre-Dame du CHUM | Montreal | Quebec |
Canada | Royal Victoria Hospital | Montreal | Quebec |
Canada | Ottawa Health Research Institute | Ottawa | Ontario |
Canada | L'Hotel-Dieu de Quebec | Quebec | |
Canada | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
Canada | The Pencer Brain Tumor Center, Princess Margaret Hospital | Toronto | Ontario |
United States | Duke University | Durham | North Carolina |
United States | Sloan-Kettering Institute for Cancer Research | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Thallion Pharmaceuticals |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the efficacy of TLN-4601 in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1). | 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1) | ||
Secondary | To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM | Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1) |
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