Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma

• Status: Completed
• Trial end date: 2015-11-10
• Target enrollment: 0
• Participant gender: All

Summary

Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan directly into participants' brain tumors. One purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan directly into brain tumors. This study will also evaluate different doses of topotecan that can be delivered to a participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also examine how their tumor responds to treatment with topotecan.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Vogelbaum, MD, PhD
• Collaborator: Infuseon Therapeutics, Inc.
• Treatments: Topotecan

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of supratentorial WHO Grade III or IV (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 of less than 40cm3 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/microliter

• Platelet count≥100,000/microliter

• Hemoglobin≥10g/dL

• Normal PT/PTT

• Estimated glomerular filtration rate (eGFR) of at least 50mL/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 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