Clinical trial · Interventional
Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan directly into participants' brain tumors. One purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan directly into brain tumors. This study will also evaluate different doses of topotecan that can be delivered to a participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also examine how their tumor responds to treatment with topotecan.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| WHO Grade III or IV Recurrent Glioma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cleveland Multiport Catheter | Device | — | UNRESOLVED |
| Gadolinium DTPA | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Direct infusion of topotecan
- description
- 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
- interventionNames
- Drug: Topotecan
- Drug: Gadolinium DTPA
- Device: Cleveland Multiport Catheter
Primary outcomes (2)
- measure
- Spatial distribution of topotecan
- timeFrame
- 24 weeks
- description
- 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
- measure
- Number of catheter- and/or drug-related complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of supratentorial WHO Grade III or IV (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 * Karnofsky Performance Status 70-100 * MRI demonstration of a stereotactically accessible enhancing mass of less than 40cm3 that does not require resection to relieve clinically significant mass effect * Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent Laboratory values within the following ranges: * Absolute neutrophil count (ANC)≥1,500/microliter * Platelet count≥100,000/microliter * Hemoglobin≥10g/dL * Normal PT/PTT * Estimated glomerular filtration rate (eGFR) of at least 50mL/min Exclusion Criteria: * Patient 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 CSF disease * Tumors involving the cerebellum * Tumor enhancement involving both hemispheres * Active infection requiring treatment * Unexplained febrile illness * Radiation or chemotherapy within 4 weeks of enrollment * Systemic diseases associated with unacceptable anesthesia or operative risk * Inability to undergo magnetic resonance imaging
References
Publications (1)
- DERIVEDVogelbaum MA, Brewer C, Barnett GH, Mohammadi AM, Peereboom DM, Ahluwalia MS, Gao S. First-in-human evaluation of the Cleveland Multiport Catheter for convection-enhanced delivery of topotecan in recurrent high-grade glioma: results of pilot trial 1. J Neurosurg. 2018 Apr 13;130(2):476-485. doi: 10.3171/2017.10.JNS171845. Print 2019 Feb 1. PMID 29652233