Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

Stopped early · Early Phase 1

Conditions studied: Brain Tumor, High Grade Glioma

In brief

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.

Key facts

Study ID

NCT02500459

Run by

Michael Vogelbaum, MD, PhD

People needed

9

Starts

2015-07-06

Expected to finish

2018-11-19

Last updated by the study team

2019-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 bleeding diathesis and a coagulation profile that would preclude patient from undergoing a neurosurgical procedure
• Subject must take anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery
• Inability to undergo magnetic resonance imaging.

Where it is running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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