Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308165
Status:
UNKNOWN
Last Update Posted:
2015-01-15
First Post:
2006-03-27
Brief Title:
Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors
Sponsor:
Jeffrey N Bruce
Organization:
Columbia University
Study Overview
Official Title:
A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors
Status:
UNKNOWN
Status Verified Date:
2015-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and efficacy of a chemotherapeutic drug topotecan as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery This drug has been used for different types of cancer but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body
This study will also evaluate advanced magnetic resonance MR imaging techniques
The study will assess quality of life parameters throughout the follow-up period
This study will also evaluate advanced magnetic resonance MR imaging techniques
The study will assess quality of life parameters throughout the follow-up period
Detailed Description:
Clinical efficacy with chemotherapy has been discouraging for malignant brain tumors mostly because of side effects and delivery limitations Because they are locally invasive and rarely metastasize malignant gliomas have features that make them uniquely amenable to new strategies of regional drug delivery Intracerebral clysis convection-enhanced delivery is a novel drug delivery strategy that uses a microinfusion pump to establish a pressure gradient in the brain via implanted catheters The pressure gradient produces convective forces that distribute a therapeutic agent throughout the tumor and surrounding brain tissue
Non-invasive magnetic resonance imaging MRI methods of monitoring drug distribution and treatment response have been developed to maximize the clinical applications and minimize complications associated with treatment risks
Study participants will be taken to the operating room to have 2 catheters surgically placed into their tumor and surrounding tumor bed These catheters will then be connected to small infusion pumps which will slowly infuse topotecan continuously over 4-5 days Patients will have daily MRI scans while in the hospital Upon completion of the experimental treatment patients will be discharged and will be followed up in the outpatient clinic
Non-invasive magnetic resonance imaging MRI methods of monitoring drug distribution and treatment response have been developed to maximize the clinical applications and minimize complications associated with treatment risks
Study participants will be taken to the operating room to have 2 catheters surgically placed into their tumor and surrounding tumor bed These catheters will then be connected to small infusion pumps which will slowly infuse topotecan continuously over 4-5 days Patients will have daily MRI scans while in the hospital Upon completion of the experimental treatment patients will be discharged and will be followed up in the outpatient clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA089395 | NIH | None | httpsreporternihgovquickSearchR01CA089395 |