Clinical trial · Interventional
Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Left institution
Summary
Brief summary (as posted)
Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into the part of the brain where the tumor has spread, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into tumor-infiltrated brain. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to treatment with topotecan. This study will also look at the way topotecan is injected into tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the brain with an MRI machine. This will allow the investigators to see where in the tumor-infiltrated brain the topotecan has been injected. This study will collect medical information before, during, and after treatment in order to better understand hot to make this type of procedure accessible to patients.
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 |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cleveland Multiport Catheter | Device | — | UNRESOLVED |
| topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intraparenchymally-administered topotecan
- description
- Patients will have topotecan administered directly into the tumor bed using convection-enhanced delivery (CED)
- interventionNames
- Drug: topotecan
- Device: Cleveland Multiport Catheter
Primary outcomes (1)
- measure
- Summary of number of adverse events by grade - A measure of treatment safety
- timeFrame
- up to 1 year after start of treatment
Secondary outcomes (3)
- measure
- The number of patients with abnormal hematology lab reports
- timeFrame
- up to 1 year after start of treatment
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 Glioma (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 surgical resection of the enhancing tumor is clinically indicated. * Karnofsky Performance Status 70-100; * MRI demonstration of an enhancing mass of more than 1 cm\^3 and less than 100 cm\^3; * Patient understands the procedures and agrees to comply with the study requirements by providing written informed consent; and * Laboratory values within the following ranges: * Absolute neutrophil count (ANC) ≥ 1,500 / μL; * Platelet count ≥ 100,000 / μL; * Hemoglobin ≥ 10 g / dL; * Estimated glomerular filtration rate (eGFR) of at least 50 mL/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 * Active infection requiring treatment; * Unexplained febrile illness; * Radiation or chemotherapy within 4 weeks of enrollment * Systemic diseases associated with unacceptable anesthesia or operative risk; * Personal or family history of bleeding diathesis and a coagulation profile that would preclude patient from undergoing a neurosurgical procedure * Subject must take anticoagulants, or antiplatelet agents, including NSAIDs that cannot be stopped for surgery * Inability to undergo magnetic resonance imaging.
References
Publications (0)
Data not yet available