Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02928575
Status:
UNKNOWN
Last Update Posted:
2016-10-10
First Post:
2016-01-14
Brief Title:
Combining Sunitinib Temozolomide and Radiation to Treat Patients Diagnosed With Glioblastoma
Sponsor:
Bassam Abdulkarim
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
A Phase II Trial of Concurrent Sunitinib Temozolomide and Radiation Therapy Followed by Adjuvant Temozolomide for Newly Diagnosed Glioblastoma Patients With an Unmethylated MGMT Gene Promoter
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a combination of Sunitinib Temozolomide and Radiation Therapy would be effective in the treatment of newly diagnosed Glioblastoma patients harboring tumors with unmethylated MGMT promoter
Detailed Description:
Glioblastoma multiforme GBM the most common primary brain tumor in adults is known for its highly invasive and angiogenic profile Despite advances in different modalities of GBM treatment the overall prognosis of GBM remains dismal The current standard of care is Radiation Therapy RT at a dose of 60 Gy 30 fractions for 6 weeks with concurrent Temozolomide TMZ 75 mgm2 daily for 6 weeks followed by adjuvant TMZ 150200mgm2 daily for 5 of 28 days x 6 months The DNA repair protein O6-methylguanine methyltransferase MGMT removes alkyl adducts at the O6 position of guanine and therefore counteracts the cytotoxic effects of alkylating agents such as TMZ Thus GBM patients harboring tumors with unmethylated MGMT promoter and increased MGMT protein expression do not derive benefit from TMZ treatment
Sunitinib Sutent SU11248 is an oral multitargeted receptor tyrosine kinase RTK inhibitor with anti-angiogenic activities Sunitinib has been approved by the FDA for the treatment of patients with gastrointestinal stromal tumors after disease progression on or intolerance to imatinib for the treatment of patients with advanced renal cell carcinoma and for the treatment of patients with unresectable locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumors pNET Previous pre-clinical data showed the efficacy of sunitinib in GBM The investigators preclinical data highlighted the differential effect of sunitinib in GBM MGMT-positive tumors with a greater response to sunitinib in combination with RT and TMZ compared to MGMT-negative tumors
In this phase II trial Investigator will test the efficacy and the safety of combining Sunitinib with RT and TMZ in newly diagnosed GBM patients displaying tumors with unmethylated MGMT promoter Based on the investigators preclinical findings patients with MGMT tumors do not derive benefit from TMZ treatment are more likely to respond to sunitinib-based therapy MGMT promoter methylation will be therefore used as a biomarker for selection of newly diagnosed GBM patients enrolled in this study
Sunitinib Sutent SU11248 is an oral multitargeted receptor tyrosine kinase RTK inhibitor with anti-angiogenic activities Sunitinib has been approved by the FDA for the treatment of patients with gastrointestinal stromal tumors after disease progression on or intolerance to imatinib for the treatment of patients with advanced renal cell carcinoma and for the treatment of patients with unresectable locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumors pNET Previous pre-clinical data showed the efficacy of sunitinib in GBM The investigators preclinical data highlighted the differential effect of sunitinib in GBM MGMT-positive tumors with a greater response to sunitinib in combination with RT and TMZ compared to MGMT-negative tumors
In this phase II trial Investigator will test the efficacy and the safety of combining Sunitinib with RT and TMZ in newly diagnosed GBM patients displaying tumors with unmethylated MGMT promoter Based on the investigators preclinical findings patients with MGMT tumors do not derive benefit from TMZ treatment are more likely to respond to sunitinib-based therapy MGMT promoter methylation will be therefore used as a biomarker for selection of newly diagnosed GBM patients enrolled in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None