Glioblastoma Clinical Trial
Official title:
A Phase I Study of Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma
This study is evaluating a combination of drugs called sirolimus and vandetanib to treat glioblastoma. Sirolimus has been approved for use in patients who undergo organ transplants. Sirolimus works by suppressing the immune system so the body will not reject the transplanted organ. Vandetanib is an investigational drug and we are trying to find the highest and safest dose of vandetanib with sirolimus that can be given safely.
- Vandetanib will be given to participants in tablet form. The dose taken will depend
upon when they are enrolled in the study. The doctor will inform them of which dose
they are on and how many tablets they will be taking.
- Sirolimus will also be given to participants in tablet form. The dose taken will depend
upon when they are enrolled in the study. The dose on the first day will be higher than
the dose taken every other day.
- Participants will also be given Bactrim, one double-strength table three times each
week (Monday, Wednesday, Friday) to help prevent participants from getting a type of
pneumonia called pneumocystis pneumonia.
- The following tests and procedures will be performed before the participants begin
taking the study drugs and before every 4 week cycle: Physical exam; medical history;
questions about any side effects; tumor assessment by MRI or CT (only before every
other cycle); Mini-Mental Status exam (MMSE); ECG (week 1, 2, 4, 8, 12, then every 3
months thereafter); blood pressure; blood tests and urine tests.
- Participants will be in this research study for a maximum of 12 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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