Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02500459
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Michael Vogelbaum, MD, PhD
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael A Vogelbaum, MD, PhD
Principal Investigator Affiliation Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, High Grade Glioma
Additional Details

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.

Arms & Interventions

Arms

Experimental: intraparenchymally-administered topotecan

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

Interventions

Drug: - topotecan

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.

Device: - Cleveland Multiport Catheter

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

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