Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
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|ClinicalTrials.gov Identifier: NCT02500459|
Recruitment Status : Terminated (PI Left institution)
First Posted : July 16, 2015
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor High Grade Glioma||Drug: topotecan Device: Cleveland Multiport Catheter||Early Phase 1|
- To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution of topotecan in tumor-infiltrated brain administered by convection-enhanced delivery (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy, following a clinically-indicated resection of the contrast enhancing tumor mass.
- To investigate by MR imaging the influence of catheter positioning, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG
- To evaluate the extent of spatial distribution of topotecan, by MR imaging, when delivered into non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium) in the intraoperative setting, the immediate peri-operative setting, and in the post-operative setting.
- To investigate the extent to which CED-mediated delivery of topotecan
- To investigate the extent to which infusate can be distributed in the 2 cm margin around the resection cavity by administration by CED
- To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different infusion rates.
- To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Undergoing A Clinically-Indicated Surgical Resection (IND 117,240)|
|Actual Study Start Date :||July 6, 2015|
|Actual Primary Completion Date :||November 19, 2018|
|Actual Study Completion Date :||November 19, 2018|
Experimental: intraparenchymally-administered topotecan
Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)
intraparenchymally-administered topotecan will use the Cleveland Multiport Catheter to directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). This drug is already FDA approved to be administered intravenously.
Device: Cleveland Multiport Catheter
The Cleveland Multiport Catheter will directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). Standard treatment is to adminsiter the drug intravenously.
- Summary of number of adverse events by grade - A measure of treatment safety [ Time Frame: up to 1 year after start of treatment ]
- The number of patients with abnormal hematology lab reports [ Time Frame: up to 1 year after start of treatment ]
- The number of patients with abnormal clinical chemistry lab reports [ Time Frame: up to 1 year after start of treatment ]
- The number of patients with abnormal coagulation lab reports [ Time Frame: up to 1 year after start of treatment ]
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): NCT02500459
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Michael A Vogelbaum, MD, PhD||Case Comprehensive Cancer Center|