Glioblastoma Clinical Trial
Official title:
An Open Label, Phase 2 Trial of Orally Administered Bosutinib (SKI-606) in Adult Patients With Recurrent Glioblastoma (GBM)
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.
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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