Glioblastoma Clinical Trial
Official title:
A Phase II Study of Tivozanib in Recurrent Glioblastoma
This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that the study drug tivozanib is still being studied. It also means
that the FDA has not yet approved tivozanib for your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking
the blood supply to the tumor, so that the tumor does not receive the nutrients it requires
to grow.
In this research study, we are looking to see what effects, good and bad, tivozanib will have
on you and your disease.
If you are willing to participate in this study, you will be asked to undergo some screening
tests and procedures that confirm you are eligible. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out taht you do not
take part in the research study. If you have had some of these tests or procedures recently,
they may or may not have to be repeated. The screening process may include the following: a
medical history, mini-mental status exam, physical exam, performance status,
electrocardiogram, blood tests, urine test. If these tests show that you are eligible to
participate in the research study, you will begin the study treatment. If you do not meet the
eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing calendar for
each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you will
be taking the study drug once daily for 3 weeks and then no study drug for the last week of
each cycle. The diary will also include special instructions for taking the study drug.
During all cycles you will have a physical exam and you will be asked questions about your
general health and specific questions about any problems that you might be having and any
medications you may be taking.
Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study
cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and
prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.
We would like to keep track of your medical condition for up to 24 months after your last
dose of study treatment. We would like to do this by calling you on the telephone once a year
to see how you are doing. Keeping in touch with you and checking your condition every year
helps us look at the long-term effects of the research study.
;
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