Finding studies
Finding studies
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Lead
Michael Vogelbaum, MD, PhD
With
This study will look at the way topotecan is injected into participant's tumor. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the tumor with an MRI machine. This will allow the investigators to see where in the tumor the topotecan has been injected. Issues related to patient selection, coordination with other therapeutic and palliative clinical options, and patient quality of life impact will be studied. Except for the infusion of topotecan and gadolinium DTPA into the tumor, and MRI imaging of the infusion process, all procedures and treatments participants will experience during the care of their brain tumor are non-investigational; the types of medical treatments, procedures, and tests they experience will be Standard of Care for patients with brain tumors. Primary Objectives: * To investigate by MR imaging the spatial and temporal distribution of topotecan in tumor and 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 * 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 recurrent/progressive HGG * To evaluate the spatial and temporal distribution of topotecan, by MR imaging, when delivered into enhancing tumor tissue versus non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium) Secondary Objectives: * To investigate the extent to which backflow may be observed on MRI during CED-mediated 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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
