Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
- 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).
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Scott Plotkin, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|