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

Glioma of Brain Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03927274
• Other study ID #: MCC-19970
• Status: Terminated
• Phase: Early Phase 1
• Start date: June 20, 2019
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glioma
• Glioma of Brain

Intervention

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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Moffitt Cancer Center Clinical Trials Website