Advanced Cancer Clinical Trial
Official title:
Phase I Study of Valproic Acid Given in Combination With Bevacizumab in Patients With Advanced Cancer to Determine Safety and Tolerability
The goal of this clinical research study is to find the highest tolerable dose of bevacizumab in combination with valproic acid that can be given to patients with advanced cancer that has not responded to standard treatment or where there is no standard treatment for the disease. The safety of this drug combination will also be studied.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels. Valproic acid works the same was way as bevacizumab and is also
used in the treatment of seizures, migraine headaches, and mood disturbances in bipolar
disorders.
If you are found to be eligible to take part in this study, you will receive the study drugs
as an outpatient. You will receive bevacizumab by vein over 90 minutes (for the first
infusion) once every 2 weeks. Once the study doctor determines that you are able to tolerate
the drug, it will be given over 60 minutes for the second infusion and then over 30 minutes
for further infusions. Valproic acid will be given by mouth (capsule(s)) each day for 28
days. You will take valproic acid once or twice a day depending on your dose. Every 28 days
is considered 1 cycle.
You will have blood drawn (about 2 teaspoons) and urine collected for routine tests every
cycle, about every 1-2 weeks, so that researchers can monitor the safety of the study drugs.
Once every 8 weeks you will have tumor markers tested as part of the routine blood draw. You
will have a physical exam once a cycle.
You will have either a CT or MRI scan of the tumor about every 8 weeks to check the status
(whether it is growing or shrinking) of the cancer. If your doctor thinks other tests are
necessary he/she will discuss those with you.
You will continue to receive bevacizumab and valproic acid as long as the disease is
considered stable. You will receive up to 12 cycles of the study drug. If the disease gets
worse or you experience any intolerable side effects, you will be taken off this study.
You will have an end-of-study visit 28 days after your last dose of bevacizumab. At this
visit, you will have a complete physical exam, including measurement of your vital signs and
blood pressure. You will have a neurological exam, and blood (about 2 teaspoons) will be
drawn for routine and tumor marker tests. You will be asked about any medications you may be
taking and whether you have had any side effects. You will also be asked how well you are
able to perform daily activities.
This is an investigational study. Bevacizumab and valproic acid are both FDA approved and
commercially available. Their use together in this study is investigational and authorized
for use in research only. Up to 80 patients will take part in this study. All will be
enrolled at MD Anderson.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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