Intratumorally-Administered Topotecan Using CED in High Grade Glioma Undergoing Stereotactic Biopsy

Inclusion Criteria:

• 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
• Karnofsky Performance Status 70-100
• MRI demonstration of a stereotactically accessible 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
  • prothrombin time (PT) / partial thromboplastin time (PTT) not above institutional norms
  • Estimated glomerular filtration rate (eGFR) of at least 50 mL/min

Exclusion Criteria:

• Patient is mentally or legally incapacitated at the time of the study
• Known HIV(+) or has been diagnosed with AIDS
• Participation in another investigational drug study in the prior 4 weeks
• Positive pregnancy test in a female
• Patient, in the opinion of the investigator, is likely to be poorly compliant
• Diffuse subependymal or cerebrospinal fluid (CSF) disease
• Tumors involving the cerebellum
• Tumor enhancement involving both hemispheres
• Active infection requiring treatment
• Unexplained febrile illness
• Radiation or chemotherapy within 4 weeks of enrollment
• Systemic diseases associated with unacceptable anesthesia or operative risk
• Inability to undergo magnetic resonance imaging