Clinical trial · Interventional
Intratumorally-Administered Topotecan Using CED in High Grade Glioma Undergoing Stereotactic Biopsy
Pilot Trial of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy (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)
The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into your brain tumor. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into your brain tumor. This study will also determine the best dose of topotecan to deliver to your tumor with use of the Cleveland Multiport Catheter and will also examine how your tumor responds to treatment with topotecan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cleveland Multiport Catheter | Device | — | UNRESOLVED |
| Lower Does Topotecan | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
| Topotecan (<=8cc) | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Predominantly enhancing mass with volume of 8 cc or less
- description
- Only 1 Cleveland Multiport Catheter (CMC) will be placed and CED will be performed intra-operatively only in a magnetic resonance imaging (MRI) equipped Operating Room. Topotecan infusion will be performed over a 4-hour period, with the goal of complete tumor coverage. The initial rate will be 1.20 ml/hour and infusion will be monitored by intermittent MRI imaging. The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent. Following completion of the 4-hour infusion, the CMC will be removed. The initial rate for each subsequent patient may be adjusted upwards in increments of up to 1.20 ml/hour based upon the tumor coverage and safety characteristics of the previously treated patients.
- interventionNames
- Drug: Topotecan (<=8cc)
- Device: Cleveland Multiport Catheter
- Diagnostic Test: Magnetic Resonance Imaging (MRI)
- type
- EXPERIMENTAL
- label
- Predominantly enhancing mass with volume of > 8 cc
- description
- 2 Cleveland Multiport Catheter (CMCs) will be placed and the total infusion rate of Topotecan per CMC to be used for the first 24 hours for the first patient will be 0.834 ml/hour (3.48 microliters/minute/microcatheter). The rate used for the second 24 hours of the infusion will be 1.668 ml/hour. If the first patient does not experience rate-limiting toxicity, then the patient #2's initial infusion rate will start at the highest tolerated rate for patient #1, and the second 24-hour rate for that patient will be increased by 0.834 ml/hour. Each subsequent patient will undergo rate escalation in a similar manner until we observe either: 1) complete coverage of the enhancing tumor by the infused Gadopentetic acid (Gd-DTPA), or 2) rate-limiting toxicity.
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 a stereotactic biopsy is indicated for confirmation of recurrence/progression * Karnofsky Performance Status 70-100 * MRI demonstration of a stereotactically accessible enhancing mass 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 / μL * Platelet count ≥ 100,000 / μL * Hemoglobin ≥ 10 g / dL * prothrombin time (PT) / partial thromboplastin time (PTT) not above institutional norms * 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 cerebrospinal fluid (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 (0)
Data not yet available