Intracerebral Clysis in Treating Patients With Recurrent Primary Brain Tumors
Patients will be hospitalized for a Stereotactic biopsy of the recurrent primary brain tumor and then have placement of two catheters into the recurrent brain tumor. Chemotherapy (Topotecan) will be slowly infused through the catheters over 4-5 days. Patients will be followed with daily MRI scans, neurological assessments and blood work throughout the hospitalization. After hospitalization there will be monthly follow-up visits, which progress to every 2 months visits. MRI scan, neurological assessments and blood work will be done at the follow-up visits.
Recurrent Anaplastic Astrocytoma
Recurrent Anaplastic Oligodendroglioma
Recurrent Anaplastic Oligo-Astrocytoma
Recurrent Glioblastoma Multiforme
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors|
- Time to tumor progression [ Time Frame: treatment to tumor progression ] [ Designated as safety issue: No ]
- Time to death [ Time Frame: treatment to time of death ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
The starting dose will be 0.02 mg/ml, and the second step will escalate the dosage by 100% (0.04 mg/ml); the third step is 67% greater than the second (0.0667 mg/ml); the fourth step is 50% greater than the third (0.1 mg/ml); and each subsequent step is 33% greater than that preceding it (5th step= 0.133; 6th step= 0.178; 7th step=0.237 mg/ml). The total volume of treatment will be 40 mL which is the volume used in previous human trials with ICC.
Other Name: Topotecan
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.
|United States, New York|
|Columbia University Department of Neurosurgery|
|New York City, New York, United States, 10032|
|Principal Investigator:||Jeffrey N Bruce, M.D.||Columbia University Department of Neurosurgery|