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Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma

Primary Purpose

Glioma of Brain

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma of Brain focused on measuring Glioma, Brain Tumor, High Grade Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 a stereotactic biopsy is indicated for confirmation of recurrence/progression.
  • 18 years of age or older
  • Karnofsky Performance Status 70-100;
  • MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect;
  • Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent
  • Adequate organ function as indicated in protocol

Exclusion Criteria:

  • Participant 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 Cerebral Spinal Fluid (CSF) disease
  • Tumors involving the cerebellum
  • Tumor enhancement involving both hemispheres
  • Active infection requiring treatment
  • Unexplained febrile illness
  • Radiation or chemotherapy within 4 weeks of enrollment
  • Systemic diseases associated with unacceptable anesthesia or operative risk
  • Inability to undergo magnetic resonance imaging (MRI)

Sites / Locations

  • Moffitt Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cleveland Multiport Catheter (CMC) + Topotecan

Arm Description

For predominantly enhanced tumors with volume of 8 cc or less, only 1 Cleveland Multiport Catheter (CMC) will be placed and convection-enhanced delivery (CED) will be performed over a 4-hour period within an MRI scanner, with the goal of complete tumor coverage (as evidenced by tracer distribution on MRI). The initial rate will be 1.20 ml/hour (5.0 microliters/minute/microcatheter) and infusion will be monitored by intermittent MRI imaging. The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent. Following completion of the 4-hour infusion, the CMC will be removed. The initial rate for each subsequent patient may be adjusted upwards in increments of up to 5 microliters/minute/microcatheter based upon the tumor coverage and safety characteristics of the previously treated patients.

Outcomes

Primary Outcome Measures

Distribution of topotecan in tumor tissue
The spatial distribution of intratumorally-administered topotecan will be determined using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction.

Secondary Outcome Measures

Number of Adverse Events (AEs) experienced by participants
Extent of topotecan backflow
Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan

Full Information

First Posted
April 23, 2019
Last Updated
May 24, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03927274
Brief Title
Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
Official Title
A Study of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding unavailable
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma of Brain
Keywords
Glioma, Brain Tumor, High Grade Glioma

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
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cleveland Multiport Catheter (CMC) + Topotecan
Arm Type
Experimental
Arm Description
For predominantly enhanced tumors with volume of 8 cc or less, only 1 Cleveland Multiport Catheter (CMC) will be placed and convection-enhanced delivery (CED) will be performed over a 4-hour period within an MRI scanner, with the goal of complete tumor coverage (as evidenced by tracer distribution on MRI). The initial rate will be 1.20 ml/hour (5.0 microliters/minute/microcatheter) and infusion will be monitored by intermittent MRI imaging. The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent. Following completion of the 4-hour infusion, the CMC will be removed. The initial rate for each subsequent patient may be adjusted upwards in increments of up to 5 microliters/minute/microcatheter based upon the tumor coverage and safety characteristics of the previously treated patients.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Intratumorally-administered topotecan using convection-enhanced delivery (CED) in patients with suspected recurrent/progressive High Grade Glioma (HGG) requiring stereotactic biopsy and is focused on investigating topotecan brain tissue distribution and determining the safety, toxicity, and tolerability of intratumorally-administered topotecan.
Primary Outcome Measure Information:
Title
Distribution of topotecan in tumor tissue
Description
The spatial distribution of intratumorally-administered topotecan will be determined using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction.
Time Frame
Treatment day 1
Secondary Outcome Measure Information:
Title
Number of Adverse Events (AEs) experienced by participants
Time Frame
Up to 48 weeks
Title
Extent of topotecan backflow
Description
Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan
Time Frame
Treatment day 1

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 a stereotactic biopsy is indicated for confirmation of recurrence/progression. 18 years of age or older Karnofsky Performance Status 70-100; MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect; Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent Adequate organ function as indicated in protocol Exclusion Criteria: Participant 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 Cerebral Spinal Fluid (CSF) disease Tumors involving the cerebellum Tumor enhancement involving both hemispheres Active infection requiring treatment Unexplained febrile illness Radiation or chemotherapy within 4 weeks of enrollment Systemic diseases associated with unacceptable anesthesia or operative risk Inability to undergo magnetic resonance imaging (MRI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Vogelbaum, M.D, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Links:
URL
http://moffitt.org
Description
Moffitt Cancer Center Clinical Trials Website

Learn more about this trial

Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma

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