Back to resultsTopotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
Primary Purpose
Brain Tumor, High Grade Glioma
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
topotecan
Cleveland Multiport Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring Topotecan, Cleveland Multiport Catheter, Cancer
Eligibility 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.
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intraparenchymally-administered topotecan
Arm Description
Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)
Outcomes
Primary Outcome Measures
Summary of number of adverse events by grade - A measure of treatment safety
Secondary Outcome Measures
The number of patients with abnormal hematology lab reports
The number of patients with abnormal clinical chemistry lab reports
The number of patients with abnormal coagulation lab reports
Full Information
NCT ID
NCT02500459
First Posted
July 15, 2015
Last Updated
February 28, 2019
Sponsor
Michael Vogelbaum, MD, PhD
Collaborators
Infuseon Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02500459
Brief Title
Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
PI Left institution
Study Start Date
July 6, 2015 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
November 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Vogelbaum, MD, PhD
Collaborators
Infuseon Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, High Grade Glioma
Keywords
Topotecan, Cleveland Multiport Catheter, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intraparenchymally-administered topotecan
Arm Type
Experimental
Arm Description
Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)
Intervention Type
Drug
Intervention Name(s)
topotecan
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cleveland Multiport Catheter
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
The number of patients with abnormal hematology lab reports
Time Frame
up to 1 year after start of treatment
Title
The number of patients with abnormal clinical chemistry lab reports
Time Frame
up to 1 year after start of treatment
Title
The number of patients with abnormal coagulation lab reports
Time Frame
up to 1 year after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Vogelbaum, MD, PhD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
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