Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme
NCT ID: NCT00730262
Last Updated: 2009-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2008-08-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-Arm
TLN-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
Interventions
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TLN-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Thallion Pharmaceuticals
INDUSTRY
Responsible Party
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Thallion Pharmaceuticals Inc.
Principal Investigators
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Warren Mason, MD
Role: PRINCIPAL_INVESTIGATOR
The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto
Locations
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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
Countries
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Other Identifiers
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TLN-4601-201
Identifier Type: -
Identifier Source: org_study_id