Bosutinib in Adult Patients With Recurrent Glioblastoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Phase 2 Trial of Orally Administered Bosutinib (SKI-606) in Adult Patients With Recurrent Glioblastoma (GBM)|
- Progression-Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess progression-free survival at six months in patients with recurrent GBM at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B)
- Intratumoral Concentration [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess the intratumoral concentration of bosutinib in recurrent GBM patients who are candidates for surgical re-resection (ARM A).
- Safety Profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Overall safety profile will be characterized by type, frequency, severity (as graded by NCI CTCAE), timing and relationship of study therapy of adverse events and laboratory abnormalities. Safety and tolerability will be measured by the proportion of patients who experience Grade 3 or higher Adverse Events that are possibly, probably or definitely related to bosutinib and the number of same Adverse Events per patient. Adverse Events will be summarized by treatment for each arm by the frequency of patients experiencing treatment emergent adverse events.
- Anti-tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]Assess anti-tumor response in patients in Arm B using MacDonald criteria.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Patients who are surgical candidates
Other Name: SKI-606
Experimental: Arm B
Patients that are not surgical candidates
Other Name: SKI-606
- 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 tests/procedures 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 tests/procedures 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331291
|Contact: Tracy Batchelor, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Tracy Batchelor, MD|
|Dana=Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Andrew Norden, MD|
|Principal Investigator:||Tracy Batchelor, MD||Massachusetts General Hospital|