Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02500459
Recruitment Status : Terminated (PI Left institution)
First Posted : July 16, 2015
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Infuseon Therapeutics, Inc.
Information provided by (Responsible Party):
Michael Vogelbaum, MD, PhD, Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Tumor High Grade Glioma Drug: topotecan Device: Cleveland Multiport Catheter Early Phase 1

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 6, 2015
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intraparenchymally-administered topotecan
Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)
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.




Primary Outcome Measures :
  1. Summary of number of adverse events by grade - A measure of treatment safety [ Time Frame: up to 1 year after start of treatment ]

Secondary Outcome Measures :
  1. The number of patients with abnormal hematology lab reports [ Time Frame: up to 1 year after start of treatment ]
  2. The number of patients with abnormal clinical chemistry lab reports [ Time Frame: up to 1 year after start of treatment ]
  3. The number of patients with abnormal coagulation lab reports [ Time Frame: up to 1 year after start of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500459


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Michael Vogelbaum, MD, PhD
Infuseon Therapeutics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Michael A Vogelbaum, MD, PhD Case Comprehensive Cancer Center

Layout table for additonal information
Responsible Party: Michael Vogelbaum, MD, PhD, Associate Director of the Brain Tumor and Neuro-Oncology Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02500459     History of Changes
Other Study ID Numbers: INFT1315
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Michael Vogelbaum, MD, PhD, Case Comprehensive Cancer Center:
Topotecan
Cleveland Multiport Catheter
Cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Topotecan
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents