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Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma | Clinical Trials | Clareo Health

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

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

NCT03927274•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+3 more criteria

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

June 20, 2019

Primary Completion Date

May 24, 2023

Completion Date

May 24, 2023

Last Updated

May 25, 2023

Enrollment

ACTUAL participants

Conditions

Glioma of Brain

Interventions

Topotecan

DRUG

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

NCT03213002

Glioblastoma Multiforme (GBM)Glioblastoma+7 more

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RECRUITING

Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients

NCT03849430

Glioma of Brain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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