Glioblastoma Clinical Trial
Official title:
An Open-Label, Phase 2 Trial of Orally Administered PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma (GBM)
There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. 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. We will determine how much PF-00299804 gets into the brain tumor by obtaining a sample of the tumor from the surgery that the participant already has scheduled. The purpose of this research study during Arm B and C, is to determine how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific proteins found on the surface of some cancer cells that promote a growth signal. Blocking this signal from reaching its target on the cancer cells may slow or stop the cancer from growing.
ARM A:
- Each treatment cycle lasts four weeks (28 days). There are no breaks from taking
PF-00299804 between treatment cycles. Participants will take PF-00299804 once a day for
a total of 7 to 9 days before surgery. They will then stop taking PF-00299804 until they
have recovered from surgery.
- Once they have recovered from surgery, they will continue to take PF-00299804 once a day
until their disease worsens, they experience side effects or they decide to stop study
treatment.
- The following tests and procedures will be performed at the time intervals specified:
Research blood tests (Day 1 of study drug administration, day of surgery, day 1 of all
cycles after surgery, day 14 of the first cycle after surgery); tissue samples (day of
surgery); physical and neuro exams (day 1 of all cycles after surgery); skin exam (day 1
of all cycles after surgery and day 14 of the first cycle after surgery).
- An assessment of the tumor by CT or MRI scan will be made within 24 hours after surgery.
Another assessment by CT or MRI scan will be made at the end of cycle 2 and then at the
end of every even numbered cycle thereafter.
ARM B & C:
- Each treatment cycle lasts four weeks (28 days). There are no breaks from taking
PF-00299804 between treatment cycles. Participants will take PF-00299804 orally once a
day until their disease worsens, they experience any side effect, or if they decide to
stop study treatment.
- Participants will come into the clinic on Day 1 and Day 14 of Cycle 1, and then on Day 1
of all subsequent cycles for some of the following tests and procedures: research blood
tests, physical and neuro exams, skin exam, urine test and Patient Reported Outcomes
questionnaire.
- An assessment of the participants tumor by CT scan or MRI scans will be done at the end
of Cycle 2, 4 and then every other cycle thereafter.
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