TerminatedEarly Phase 1

Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

Stopped: PI Left institution

United States9 participantsStarted 2015-07-06

Plain-language summary

Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into the part of the brain where the tumor has spread, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into tumor-infiltrated brain. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to treatment with topotecan. This study will also look at the way topotecan is injected into tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the brain with an MRI machine. This will allow the investigators to see where in the tumor-infiltrated brain the topotecan has been injected. This study will collect medical information before, during, and after treatment in order to better understand hot to make this type of procedure accessible to patients.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 surgical resection of the enhancing tumor is clinically indicated. * Karnofsky Performance Status 70-100; * MRI demonstration of an enhancing mass of more than 1 cm\^3 and less than 100 cm\^3; * Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent; and * Laboratory values within the following ranges: * Absolute neutrophil count (ANC) ≥ 1,500 / μL; * Platelet count ≥ 100,000 / μL; * Hemoglobin ≥ 10 g / dL; * 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 CSF disease; * Tumors involving the cerebellum * Active infection requiring treatment; * Unexplained febrile illness; * Radiation or chemotherapy within 4 weeks of enrollment * Systemic diseases associated with unacceptable anesthesia or operative risk; * Personal or family history of bleedin…

What they're measuring

Summary of number of adverse events by grade - A measure of treatment safety

Timeframe: up to 1 year after start of treatment

Trial details

NCT IDNCT02500459

SponsorMichael Vogelbaum, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-19