A Phase I/II Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors
Candidates will be screened with a physical examination, neurological examination, Karnofsky
performance status, magnetic resonance imaging (MRI) of the brain, and routine laboratory
tests. Eligible candidates will be admitted to the hospital for Stereotactic biopsy of the
recurrent brain tumor and then have placement of two catheters into the tumor. It will be
followed with 4-5 days of a slow infusion of Topotecan directly into the tumor using the
catheter and microinfusion pump. Candidates will be evaluated daily with MRI of the brain
and neurological exam. Once the infusion of Topotecan is complete and the catheters are
discontinued, the candidate is discharged home in approximately 24 hours. Follow-up visits
after hospitalization will be monthly for four visits and then every eight weeks. At each
follow-up visit a neurological exam, Karnofsky performance status, routine laboratory tests
and a MRI of the brain will be performed.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to tumor progression
treatment to tumor progression
No
Jeffrey N Bruce, M.D.
Principal Investigator
Columbia University Department of Neurosurgery
United States: Food and Drug Administration
AAAA4229 (I/II)
NCT00452959
October 2003
March 2013
Name | Location |
---|---|
Columbia University Department of Neurosurgery | New York City, New York 10032 |