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Neoplasms, Glandular and Epithelial

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All Drugs and Chemicals

Topotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

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

Glioblastoma

Astrocytoma

Immunomodulating Agents

D2C7-(scdsFv)-PE38KDEL

Immunoconjugates

Immunologic Factors

Single D2C7-IT intratumoral infusion (6920 ng/mL in 36 mL) over 72 hours followed by single 2141-V11 infusion (5 dose levels) over 7 hours followed by an injection of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor at week 2, radiation, and further injections of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor.

D2C7-IT will be dosed at 166,075 ng in 36 mL.

D2C7-IT

2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.

2141-V11

Daniel Landi, MD

Stevie Threatt

Annick Desjardins, MD

The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).

Within this study, approximately 50 study participants will receive a single infusion of D2C7-IT in the hospital, which is delivered to the tumor margins over 3 days through a catheter placed in the brain, followed by a single infusion of 2141-V11 delivered over 7 hours to the tumor margins through the same catheter. About 2 weeks after intratumoral infusion of D2C7-IT and 2141-V11, participants will have their first subcutaneous (under the skin) injection of 2141-V11 in the area around the lymph nodes of the head and neck on the same side as the tumor. About a week after this injection, participants will start standard radiation therapy (RT), which typically lasts either 3 weeks or 6 weeks depending upon age. Once RT is finished, participants will resume injections in the area around the lymph nodes of the head and neck on the same side as the tumor of 2141-V11 about 1 week later. They will have another injection about 3 weeks after finishing RT and then start a schedule of injections about every 3 weeks for up to a year.

There are risks to the study drugs that are described in this document. Some common risks related to D2C7-IT include: effects related to tumor cells dying (tumor necrosis), effects on normal brain tissue, effects related to catheter placement and removal, effects related to fluid infusion into the brain (intracerebral infusion), and reactions to the D2C7-IT being directly infused in your brain. Risks of 2141-V11 being directly infused in your brain and injected in the area around the lymph nodes of the head and neck could include: cytokine release syndrome (release of immune system cells called cytokines that can cause fever, chills, headache, muscle pain, itching, rash, chest tightness, palpitations, shortness of breath, low blood pressure, nausea, vomiting), swelling and redness in the neck area, overstimulation of your immune system such that it attacks other tissues in your body, elevated liver enzymes, and low platelets in the blood.

D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

Delivery of D2C7-IT and 2141-V11 Combination Immunotherapy in Residual Disease for Adult Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma and Perilymphatic Subcutaneous Injections of 2141-V11

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
D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients	NCT05734560	Newly Diagnosed...	D2C7-IT 2141-V11	18 Years -	Duke University

Spots Global Cancer Trial Database for ced

Every month we try and update this database with for ced cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for ced

Every month we try and update this database with for ced cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ced cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.