Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
|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 ]
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|