Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT02278510|
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : March 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma WHO Grade III or IV Recurrent Glioma||Drug: Topotecan Drug: Gadolinium DTPA Device: Cleveland Multiport Catheter||Early Phase 1|
This study will look at the way topotecan is injected into participant's tumor. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the tumor with an MRI machine. This will allow the investigators to see where in the tumor the topotecan has been injected. Issues related to patient selection, coordination with other therapeutic and palliative clinical options, and patient quality of life impact will be studied. Except for the infusion of topotecan and gadolinium DTPA into the tumor, and MRI imaging of the infusion process, all procedures and treatments participants will experience during the care of their brain tumor are non-investigational; the types of medical treatments, procedures, and tests they experience will be Standard of Care for patients with brain tumors.
- To investigate by MR imaging the spatial and temporal distribution of topotecan in tumor and 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
- To investigate by MR imaging the influence of the rate and topotecan concentration, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG
- To evaluate the spatial and temporal distribution of topotecan, by MR imaging, when delivered into enhancing tumor tissue versus non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium)
- To investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan
- To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and 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 :||3 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 Requiring Stereotactic Biopsy|
|Actual Study Start Date :||December 9, 2014|
|Actual Primary Completion Date :||November 10, 2015|
|Actual Study Completion Date :||November 10, 2015|
Experimental: Direct infusion of topotecan
The experimental Cleveland Multiport Catheter will be used to inject a chemotherapy, topotecan, and a contrast agent, gadolinium DTPA, into the high grade brain tumors of study participants
Topotecan is a chemotherapy that is approved by the FDA to treat cancers. It is normally given by an intravenous injection, and not directly into a tumor. That is why it is considered to be an investigational drug for this study
Drug: Gadolinium DTPA
Gadolinium DTPA is a contrast agent which will be added to topotecan to allow the investigators to observe where topotecan goes in tumors. Gadolinium DTPA is approved by the FDA for intravenous injection during an MRI scan. It is not approved by the FDA for administration directly into a tumor.
Device: Cleveland Multiport Catheter
The Cleveland Multiport Catheter is a device that is not approved by the FDA and so it is classified as an investigational device. It has been designed to deliver drugs and other agents intended to treat cancers directly into the affected tissues. The Cleveland Multiport Catheter can be placed into a brain tumor only in the operating room. It is placed during an operation to perform a biopsy of brain tumors. Following the biopsy, a surgeon will place two catheters into the tumor with use of an image guided navigation system. Once each catheter has been placed, it will be secured into the scalp and the incision will be closed. The Cleveland Multiport Catheter will be left in place until the completion of the topotecan treatment.
- Spatial distribution of topotecan [ Time Frame: 24 weeks ]Determination of the spatial distribution of intraparenchymally-administered topotecan over time using a gadolinium-based contrast agent, volumetric magnetic resonance imaging, and three-dimensional image reconstruction
- Number of catheter- and/or drug-related complications [ Time Frame: 24 weeks ]The overall number of catheter- and/or drug-related complications occurring intra-operatively, post-operatively, or following catheter removal
- Objective response rate of subjects given topotecan [ Time Frame: 24 weeks ]The mean objective response rate to using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive HGG administered via CED.
- Median progression-free survival of HGG subjects given topotecan [ Time Frame: 24 weeks ]The median progression-free survival of subjects in months using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive GBM administered via CED.
- Median overall survival of HGG subjects given topotecan [ Time Frame: 24 weeks ]The median overall survival of subjects in months using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive GBM administered via CED.
- Proportion of progression free HGG subjects given topotecan [ Time Frame: 24 weeks ]The proportion of subjects without disease progression using the Response Assessment in Neuro-Oncology (RANO) criteria for single-agent topotecan in recurrent/progressive GBM administered via CED.
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): NCT02278510
|United States, Ohio|
|Cleveland Clinic, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Michael A Vogelbaum, MD, PhD||Cleveland Clinic, Case Comprehensive Cancer Center|