Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT00821080|
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : May 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Sirolimus Drug: Vandetanib||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Vandetanib and Sirolimus
Single arm study
Taken orally at different dose levels depending upon enrollment time periodDrug: Vandetanib
Taken orally at different dose levels depending upon enrollment time period
- To determine the optimal, safe dose of vandetanib in combination with sirolimus. MTD and dose-limiting toxicity (DLT) of this combination therapy will also be established [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821080
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Instiute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Tracy Batchelor, MD||Massachusetts General Hospital|