A Pilot Trial of Intratumorally-Administered Topotecan using Convection-Enhanced Delivery (CED) in Patients with Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy (IND 117,240)
- 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
Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression.
18 years of age or older
Karnofsky Performance Status 70-100;
MRI demonstration of a stereotactically accessible enhancing or predominantly non-enhancing mass that does not require resection to relieve clinically significant mass effect;
Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent
Laboratory values within the following ranges: Absolute neutrophil count (ANC) ≥ 1,500 / μL, Platelet count ≥ 100,000 / μL, Hemoglobin ≥ 10 g / dL, PT/PTT not above institutional norms, Estimated glomerular filtration rate (eGFR) of at least 50 mL/min
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