Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01331291
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2011-03-28
Brief Title:
Bosutinib in Adult Patients With Recurrent Glioblastoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
An Open Label Phase 2 Trial of Orally Administered Bosutinib SKI-606 in Adult Patients With Recurrent Glioblastoma GBM
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
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:
For many brain tumors one reason that chemotherapy drugs might not be effective is that the drug may not be able to get into the brain tumor and kill the cancer cells The brain is protected by a layer called the blood brain barrier This barrier prevents substances from entering The purpose of this research study is to determine if bosutinib can get past the blood brain barrier and into the brain tumor and to see how well bosutinib works in killing cancer cells
Detailed Description:
- Arm A Participants will receive daily doses of bosutinib orally for 7-9 days prior to surgery On the day of the scheduled surgery either craniotomy or surgical resection as planned by the treating doctor participants will take the bosutinib within 6-12 hours of the surgery During the surgery tissue samples of the tumor will be collected to test the levels of bosutinib in the brain A contrast-enhanced MRI or CT scan will be done within days after the surgery Daily dosing of bosutinib will resume after a recovery period of 10 days From then on the study will be divided into 28-day cycles
The following testsprocedures will be performed regularly during cycles of study treatment medical history physical exam blood tests contrast-enhanced CT or MRI scans even numbered cycles only
Arm B Participants will receive daily doses of bosutinib The study is divided int 28-day cycles There are no breaks from taking bosutinib between treatment cycles The following testsprocedures will be performed regularly during cycles of study treatment medical history physical exam blood tests contrast-enhanced CT or MRI scans even numbered cycles only
Participants may continue to receive daily bosutinib until their disease worsens they experience unmanageable side-effects or they decide to stop treatment
The following testsprocedures will be performed regularly during cycles of study treatment medical history physical exam blood tests contrast-enhanced CT or MRI scans even numbered cycles only
Arm B Participants will receive daily doses of bosutinib The study is divided int 28-day cycles There are no breaks from taking bosutinib between treatment cycles The following testsprocedures will be performed regularly during cycles of study treatment medical history physical exam blood tests contrast-enhanced CT or MRI scans even numbered cycles only
Participants may continue to receive daily bosutinib until their disease worsens they experience unmanageable side-effects or they decide to stop treatment
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