Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06666712 · ClinicalTrials.gov registry record · Phase 1
Chronic CED of TPT for Recurrent Malignant Glioma
A Phase 1 study of Brain Tumor, Recurrent and Malignant Glioma (WHO Grade III or IV), sponsored by Jeffrey N. Bruce.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06666712: Recruiting Phase 1 study of Brain Tumor, Recurrent and Malignant Glioma (WHO Grade III or IV), sponsored by Jeffrey N. Bruce.
NCT06666712 is a Phase 1 study of Brain Tumor, Recurrent and Malignant Glioma (WHO Grade III or IV) that is actively recruiting participants, run by Jeffrey N. Bruce. The registered enrollment target is 6 participants, below the 112-participant average among 6 other Brain Tumor, Recurrent trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06666712, a Phase 1 study of Brain Tumor, Recurrent and Malignant Glioma (WHO Grade III or IV), is actively recruiting participants, sponsored by Jeffrey N. Bruce.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary goal of this study is to establish the safety of chronic Convection Enhanced Delivery (CED) of the chemotherapeutic drug Topotecan for patients with recurrent malignant glioma that harbors the Isocitrate Dehydrogenase mutation (IDH-mut). The secondary goal of the study is to study drug distribution and assess the tumor response to prolonged continuous CED of Topotecan. Convection Enhanced Delivery is a novel method of drug delivery that allows administration of a drug directly to the brain. In CED, a drug pump is placed under the skin in the chest or abdominal region. The pump is connected to a catheter that is tunneled underneath the skin to the brain. The tip of the catheter then infuses Topotecan directly onto the brain tumor. There will be a total of four treatment infusions over the course of 23-29 days, with a 5-7-day rest period between each infusion. Throughout this period, patients' health will be monitored through imaging, blood draws, and regular exams. At the end of the treatment period, the pump will be removed, followed by resection of the tumor. Patients will be followed for the duration of their lives. This is the investigator's second clinical trial studying CED of TPT in recurrent glioma. In the prior Phase 1b trial, chronic pulsatile CED safely and effectively delivered Topotecan to patients with IDH mutant recurrent Glioblastoma (WHO grade 4).
Primary Outcome
The primary outcome of the study is to measure the safety of prolonged CED of Topotecan in patients with recurrent IDH-mutant malignant glioma. Safety is defined as the dose at which all patients have had no greater than grade 2 adverse reactions possibly, probably, or definitely related to CED of Topotecan as measured through physical and neurologic examination, laboratory studies, radiographic studies, and adverse effects, as defined by the Common Terminology Criteria for Adverse Events (CTCAE
Conditions Studied
Interventions
- DRUG Topotecan
Study Locations (1)
New York
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2026-03 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
What NCT06666712 shows while recruiting
NCT06666712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 112-participant average among 6 other Brain Tumor, Recurrent trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Brain Tumor, Recurrent appearing as the primary indexed condition, and to 1 intervention - of which Topotecan is the first listed.
NCT06666712 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06666712 about?
NCT06666712 is a clinical study titled "Chronic CED of TPT for Recurrent Malignant Glioma". The primary goal of this study is to establish the safety of chronic Convection Enhanced Delivery (CED) of the chemotherapeutic drug Topotecan for patients with recurrent malignant glioma that harbors the Isocitrate Dehydrogenase mutation (IDH-mut). The secondary goal of the study is to study drug d...
What is the current status of trial NCT06666712?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2026-03. Estimated completion is 2028-06.
What conditions does trial NCT06666712 study?
This clinical trial studies the following conditions: Brain Tumor, Recurrent, Malignant Glioma (WHO Grade III or IV), IDH1/IDH2 Mutation.
What interventions are being tested in trial NCT06666712?
The interventions under investigation include: Topotecan (DRUG).
Who is sponsoring clinical trial NCT06666712?
This trial is sponsored by Jeffrey N. Bruce, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06666712 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Tumor, Recurrent
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors
ACTIVE NOT RECRUITING · Phase 1
-
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
COMPLETED · Phase 1
-
Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors
COMPLETED · Phase 1
-
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
RECRUITING · Phase 2
-
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
RECRUITING
-
Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)
ACTIVE NOT RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia