Glioblastoma Clinical Trial
Official title:
A Phase II Trial of Cilengitide Plus Bevacizumab in Patients With Recurrent Glioblastoma
The goal of this clinical research study is to learn if cilengitide given in combination with
bevacizumab can help to control glioblastoma. The safety of this drug combination will also
be studied.
Cilengitide is designed to block the flow of blood to cancer cells, which may help to slow or
block the growth of cancer.
Bevacizumab is designed to block the growth of new blood vessels, which may help to slow or
block the growth of cancer.
Study Drug Administration:
Each study cycle is 4 weeks. The length of any study cycle may be extended if you experience
side effects from the drugs.
Cilengitide will be given as an intravenous (IV) infusion (into a vein) 2 times a week during
each 4-week cycle. The infusion will last about 1 hour each time and will be separated by at
least 72 hours.
Bevacizumab will be given on as an IV infusion over 90 minutes on Days 1 and 15 of each
cycle. After several infusions and depending on how you react, the length of time of the
infusion may decrease.
If the study doctor thinks it is in your best interest and depending on how you react to
bevacizumab, the length of the infusion time may be decreased.
On the days you are scheduled to receive both cilengitide and bevacizumab, you will receive
cilengitide after the bevacizumab infusion.
Study Visits:
On Day 1 of Cycle 1, urine and blood (about 1 tablespoon) will be collected for routine
tests.
On Day 15 of Cycle 1, your blood pressure will be measured and blood (about 1 tablespoon)
will be drawn for routine tests.
Day 1 of Cycles 2 and beyond:
- You will have a physical exam including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will complete the MDASI-BT questionnaire.
- Urine and blood (about 1 tablespoon) will be drawn for routine tests.
- You will have a CT or MRI scan to check the status of the disease (only at Cycles 2, 4,
6, 8, and so on.)
On Day 15 of Cycles 2 and beyond, your blood pressure will be measured.
End-of-Treatment Visit:
After your last dose of the study drugs, you will have and end-of-treatment visit and the
following tests and procedures will be performed:
- You will have a physical exam including measurement of your weight and vitals.
- Your performance status will be recorded.
- You will have a neurologic exam.
- Your performance status will be recorded.
- You will complete the MDASI-BT questionnaire.
- Urine and blood (about 1 tablespoon) will be collected for routine tests.
- You will have a CT or MRI scan to check the status of the disease.
Length of Treatment:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the long-term follow-up phone calls.
Long-Term Follow-Up Visit:
After you have stopped taking the study drugs and completed your end-of-treatment visit, the
study staff will call you 1 time every 6 months to check on how you are doing. Each phone
call should last about 5 minutes.
This is an investigational study. Bevacizumab is FDA approved and commercially available for
the treatment of recurrent glioblastoma. Cilengitide is not FDA approved or commercially
available. At this time, the combination of cilengitide and bevacizumab is being used for
research purposes only.
Up to 39 participants will take part in this multicenter study. Up to 20 will be enrolled at
MD Anderson.
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