Brain Neoplasms, Primary Malignant Clinical Trial
Official title:
A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01638130 -
Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers
|
N/A |