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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00730262
• Other study ID #: TLN-4601-201
• Status: Terminated
• Phase: Phase 2
• First received: August 6, 2008
• Last updated: December 29, 2009
• Start date: August 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2009
• Source: Thallion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 post surgery/radiotherapy.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• TLN-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Thallion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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)