Glioma Clinical Trial
Official title:
Pilot Trial of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy (IND 117,240)
The purpose of this study is to determine if treatment with topotecan by an alternative
method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland
Multiport Catheter is a new, investigational device that will be used to deliver topotecan
into your brain tumor. A second purpose of this study is to determine whether the Cleveland
Multiport Catheter can be used effectively and safely to deliver topotecan into your brain
tumor.
This study will also determine the best dose of topotecan to deliver to your tumor with use
of the Cleveland Multiport Catheter and will also examine how your tumor responds to
treatment with topotecan.
Primary Objectives
- To investigate by MR imaging the spatial and temporal distribution of topotecan in
enhancing or nonenhancing bulk tumor administered by convection-enhanced delivery (CED)
in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who
have failed standard therapy comprising surgical biopsy and/or resection and adjuvant
chemotherapy and radiotherapy.
- To investigate by MR imaging the influence of the rate and topotecan concentration, on
the spatial and temporal distribution of topotecan administered by CED in patients with
with recurrent/progressive HGG
Secondary Objectives
- To investigate the extent to which backflow may be observed on MRI during CEDmediated
delivery of topotecan
- To assess the safety, tolerability and toxicity profile of topotecan administered by CED
using different doses and infusion rates.
- To observe evidence of activity of single-agent topotecan administered by CED to
patients with recurrent/progressive HGG who have failed standard therapy comprising
surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.
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