Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
|ClinicalTrials.gov Identifier: NCT00864864|
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Brain Tumor||Drug: Sunitinib||Early Phase 1|
- Participants will take the study drug, sunitinib, for 7 days prior to their surgery. The surgery is part of the routine care for glioblastoma and will be performed on Day 8. The study drug is supplied in capsule form and is to be taken at home.
- On Day 7 participants will come to the clinic and have the following tests and procedures performed: Neurological and physical examination; vital signs; and blood samples. On day 9 (the day after the surgery) an MRI scan will be performed.
- Fourteen days after the participants surgery (Day 22), they will restart sunitinib treatment. They will take the study drug once a day for 4 weeks followed by a 2 week rest period (no study drug treatment). This 6 week period is called a cycle of study treatment. Participants can continue to receive cycles of study treatment as long as their disease does not progress and they do not experience any serious side-effects.
- Before each new cycle of study treatment (once every 6 weeks) the participant will come into the clinic for the following tests: Neurological and physical examination; vital signs; blood sample; urine sample; MRI scan of the brain (done every even cycle).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2013|
U.S. FDA Resources
Taken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period
- To assess the ability of sunitinib to achieve a target tumor: plasma ration greater than or equal to 0.2 in patients with recurrent GM. [ Time Frame: 3 years ]
- To determine if there is an association between growth factor receptor inhibition and tumor phenotype, tumor: plasma ratio of sunitinib and overall survival. [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864864
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Scott Plotkin, MD, PhD||Massachusetts General Hospital|