Finding studies
Finding studies
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Lead
Michael Vogelbaum, MD, PhD
With
Primary Objectives * To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution of topotecan in tumor-infiltrated brain 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, following a clinically-indicated resection of the contrast enhancing tumor mass. * To investigate by MR imaging the influence of catheter positioning, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG * To evaluate the extent of spatial distribution of topotecan, by MR imaging, when delivered into non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium) in the intraoperative setting, the immediate peri-operative setting, and in the post-operative setting. Secondary Objectives * To investigate the extent to which CED-mediated delivery of topotecan * To investigate the extent to which infusate can be distributed in the 2 cm margin around the resection cavity by administration by CED * To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
