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Brief Title: Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma
Official Title: A Phase I Study of Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma
Study ID: NCT00821080
Brief Summary: 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.
Detailed Description: * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Instiute, Boston, Massachusetts, United States
Name: Tracy Batchelor, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR