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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05023551 -
Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
|
Early Phase 1 | |
Recruiting |
NCT06059690 -
Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells
|
Phase 1/Phase 2 | |
Recruiting |
NCT04116411 -
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
|
Phase 2 | |
Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00038493 -
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Recruiting |
NCT01923922 -
CT Perfusion in the Prognostication of Cerebral High Grade Glioma
|
N/A | |
Completed |
NCT01956734 -
Virus DNX2401 and Temozolomide in Recurrent Glioblastoma
|
Phase 1 | |
Completed |
NCT01301430 -
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
|
Phase 1/Phase 2 | |
Completed |
NCT01402063 -
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
|
Phase 2 | |
Suspended |
NCT01386710 -
Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00995007 -
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
|
Phase 2 | |
Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Terminated |
NCT00990496 -
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
|
Phase 1 | |
Completed |
NCT00402116 -
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00504660 -
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
|
Phase 2 | |
Recruiting |
NCT05366179 -
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
|
Phase 1 |