Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
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|ClinicalTrials.gov Identifier: NCT03927274|
Recruitment Status : Suspended (Supply chain issue with catheters used in trial)
First Posted : April 25, 2019
Last Update Posted : March 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Glioma of Brain||Drug: Topotecan||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2022|
|Estimated Study Completion Date :||December 2022|
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.
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927274
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Michael Vogelbaum, M.D, PhD||Moffitt Cancer Center|