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Topotecan

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The experimental Cleveland Multiport Catheter will be used to inject a chemotherapy, topotecan, and a contrast agent, gadolinium DTPA, into the high grade brain tumors of study participants

Topotecan is a chemotherapy that is approved by the FDA to treat cancers. It is normally given by an intravenous injection, and not directly into a tumor. That is why it is considered to be an investigational drug for this study

Gadolinium DTPA is a contrast agent which will be added to topotecan to allow the investigators to observe where topotecan goes in tumors. Gadolinium DTPA is approved by the FDA for intravenous injection during an MRI scan. It is not approved by the FDA for administration directly into a tumor.

Gadolinium DTPA

The Cleveland Multiport Catheter is a device that is not approved by the FDA and so it is classified as an investigational device. It has been designed to deliver drugs and other agents intended to treat cancers directly into the affected tissues. The Cleveland Multiport Catheter can be placed into a brain tumor only in the operating room. It is placed during an operation to perform a biopsy of brain tumors. Following the biopsy, a surgeon will place two catheters into the tumor with use of an image guided navigation system. Once each catheter has been placed, it will be secured into the scalp and the incision will be closed. The Cleveland Multiport Catheter will be left in place until the completion of the topotecan treatment.

Cleveland Multiport Catheter

Michael A Vogelbaum, MD, PhD

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.

This study will look at the way topotecan is injected into participant's tumor. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the tumor with an MRI machine. This will allow the investigators to see where in the tumor the topotecan has been injected. Issues related to patient selection, coordination with other therapeutic and palliative clinical options, and patient quality of life impact will be studied. Except for the infusion of topotecan and gadolinium DTPA into the tumor, and MRI imaging of the infusion process, all procedures and treatments participants will experience during the care of their brain tumor are non-investigational; the types of medical treatments, procedures, and tests they experience will be Standard of Care for patients with brain tumors.

Primary Objectives:

* To investigate by MR imaging the spatial and temporal distribution of topotecan in tumor and tumor-infiltrated brain 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 recurrent/progressive HGG
* To evaluate the spatial and temporal distribution of topotecan, by MR imaging, when delivered into enhancing tumor tissue versus non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium)

Secondary Objectives:

* To investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan
* To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and infusion rates
* To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy

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

A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Requiring Stereotactic Biopsy

Determination of the spatial distribution of intraparenchymally-administered topotecan over time using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction

The overall number of catheter- and/or drug-related complications occurring intra-operatively, post-operatively, or following catheter removal

The mean objective response rate to using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive HGG administered via CED.

The median progression-free survival of subjects in months using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive GBM administered via CED.

The median overall survival of subjects in months using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive GBM administered via CED.

The proportion of subjects without disease progression using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive GBM administered via CED.

Infuseon Therapeutics, Inc.

Michael Vogelbaum, MD, PhD

Principal Investigator

Nervous System Diseases

Brain Neoplasms

Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)

intraparenchymally-administered topotecan will use the Cleveland Multiport Catheter to directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). This drug is already FDA approved to be administered intravenously.

topotecan

The Cleveland Multiport Catheter will directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). Standard treatment is to adminsiter the drug intravenously.

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.

Primary Objectives

* To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution of topotecan in tumor-infiltrated brain 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, following a clinically-indicated resection of the contrast enhancing tumor mass.
* To investigate by MR imaging the influence of catheter positioning, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG
* To evaluate the extent of spatial distribution of topotecan, by MR imaging, when delivered into non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium) in the intraoperative setting, the immediate peri-operative setting, and in the post-operative setting.

Secondary Objectives

* To investigate the extent to which CED-mediated delivery of topotecan
* To investigate the extent to which infusate can be distributed in the 2 cm margin around the resection cavity by administration by CED
* To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different infusion rates.
* To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.

Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Undergoing A Clinically-Indicated Surgical Resection (IND 117,240)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma	NCT02278510	Malignant Gliom... WHO Grade III o...	Topotecan Gadolinium DTPA Cleveland Multi...	18 Years -	Case Comprehensive Cancer Center
Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection	NCT02500459	Brain Tumor High Grade Glio...	topotecan Cleveland Multi...	18 Years -	Case Comprehensive Cancer Center

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