Clinical Trials /

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

NCT03927274

Description:

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.

Related Conditions:
  • Malignant Glioma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: MCC-19970
  • NCT ID: NCT03927274

Conditions

  • Glioma of Brain

Interventions

DrugSynonymsArms
TopotecanCleveland Multiport Catheter (CMC) + Topotecan

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cleveland Multiport Catheter (CMC) + TopotecanExperimentalFor 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.
  • Topotecan

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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Distribution of topotecan in tumor tissue
Time Frame:Treatment day 1
Safety Issue:
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.

Secondary Outcome Measures

Measure:Number of Adverse Events (AEs) experienced by participants
Time Frame:Up to 48 weeks
Safety Issue:
Description:
Measure:Extent of topotecan backflow
Time Frame:Treatment day 1
Safety Issue:
Description:Investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • Glioma
  • Brain Tumor
  • High Grade Glioma

Last Updated

July 6, 2020