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出境医 / 临床实验 / Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma

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

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.

Condition or disease Intervention/treatment Phase
Glioma of Brain Drug: Topotecan Early Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Cleveland Multiport Catheter (CMC) + Topotecan
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.
 Drug: Topotecan
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.
Outcome Measures
Primary Outcome Measures :
  1. Distribution of topotecan in tumor tissue [ Time Frame: Treatment day 1 ]
    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 :
  1. Number of Adverse Events (AEs) experienced by participants [ Time Frame: Up to 48 weeks ]
  2. Extent of topotecan backflow [ Time Frame: Treatment day 1 ]
    Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan


Eligibility Criteria
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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 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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jerry Owens 813-745-1656 Jerry.Owens@Moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jerry Owens    813-745-1656    Jerry.Owens@Moffitt.org   
Contact       Jerry.Owens@Moffitt.org   
Principal Investigator: Michael Vogelbaum, MD, PhD         
Sub-Investigator: Peter Forsyth, M.D.         
Sub-Investigator: James Liu, M.D.         
Sub-Investigator: Sepideh Mokhtari, M.D         
Sub-Investigator: Edwin Peguero, M.D         
Sub-Investigator: Solmaz Sahebjam, M.D         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Michael Vogelbaum, M.D, PhD Moffitt Cancer Center
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		Distribution of topotecan in tumor tissue [ Time Frame: Treatment day 1 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Number of Adverse Events (AEs) experienced by participants [ Time Frame: Up to 48 weeks ]
  • Extent of topotecan backflow [ Time Frame: Treatment day 1 ]
    Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioma of Brain
Intervention  ICMJE Drug: Topotecan
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.
Study Arms  ICMJE Experimental: Cleveland Multiport Catheter (CMC) + Topotecan
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: Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jerry Owens 813-745-1656 Jerry.Owens@Moffitt.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927274
Other Study ID Numbers  ICMJE MCC-19970
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Vogelbaum, M.D, PhD Moffitt Cancer Center
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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