NCT06666712 Chronic CED of TPT for Recurrent Malignant Glioma
| NCT ID | NCT06666712 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jeffrey N. Bruce |
| Condition | Brain Tumor, Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2026-06-12 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Patients must have recurrent malignant glioma with a history of WHO grade 3-4 IDH-mutant status and evidence of radiographic progression and suspicion of histopathological recurrence. Stereotactic biopsies will be performed to assess the presence of active tumor by frozen section prior to initiating treatment. Patients with a history of WHO grade 2 recurrent glioma, IDH-Mutant, who now demonstrate high-grade features of IDH-mutant WHO grade 3-4 will also be included. 2. Patients with recurrent malignant glioma, IDH-mutant, who have failed standard of care treatment are eligible. 3. An MRI scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect. Tumors must be less than 32 cc in total volume as assessed by the principal investigator based on pre-enrollment MRI. The lesion must be stereotactically accessible. 4. Karnofsky performance score must be greater than or equal to 70. 5. Men and women of childbearing potential must practice birth control. Women of childbearing potential must have a urine pregnancy test within 7 days of study entry. In accordance with topotecan administration guidelines, women must practice birth control for at least 1 month following chemotherapy infusion. Men must practice birth control for at least four months following termination of chemotherapy infusion. 6. Patients or appropriate legally authorized representatives must possess the ability to give Informed Consent. 7. Patients must be willing to and medically capable of undergoing the surgical operation. 8. Patients must be at least 18 years old. 9. Patients must not have known abnormal organ and marrow function as defined below 14 days or fewer from registration: * Leukocytes: ≥3,000/mcL * Absolute neutrophil count : ≥1,500/mcL * Platelets: ≥100,000/mcL * Total bilirubin: within normal institutional limits * AST(SGOT)/ALT(SGPT): ≤2.5 × institutional upper limit of normal * Creatinine: within normal institutional limits OR * Creatinine clearance: ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. Exclusion Criteria: 1. Patients with diffuse subependymal or CSF disease. 2. Patients with tumors involving the cerebellum or both cerebral hemispheres. 3. Patients with an active infection requiring treatment or having an unexplained febrile illness. 4. Patients who are known HIV, Hepatitis B or Hepatitis C positive. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Topotecan. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. HIV, Hepatitis B and Hepatitis C testing is not required for patients not known to have these infections. 5. Patients with systemic diseases which may be associated with unacceptable anesthetic/operative risk. 6. Patients who have previously received systemic topotecan for their tumor. 7. Patients who are not able to receive MRI or PET scans. 8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan, other topoisomerase inhibitors or gadolinium compounds. 9. Patients who are currently receiving treatment with agents that are metabolized solely through cytochrome P450 (CYP) 3A4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong CYP2C8 inhibitors. Patients who are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates are also ineligible. Caution should be used in patients taking other CYP2C8 - or CYP3A4/5-interacting agents as they may increase the serum concentrations of topotecan. If previously on such agents, the patient must discontinue them for at least two weeks prior to study treatment. 10. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing active infection, systemic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 11. Women of childbearing potential who fail to demonstrate a negative pregnancy test 7 or fewer days from registration. 12. Women who are breast-feeding.
Contact & Investigator
Jeffrey Bruce, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06666712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Tumor, Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06666712 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06666712 currently recruiting?
Yes, NCT06666712 is actively recruiting participants. Contact the research team at jnb2@cumc.columbia.edu for enrollment information.
Where is the NCT06666712 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06666712 clinical trial?
NCT06666712 is sponsored by Jeffrey N. Bruce. The principal investigator is Jeffrey Bruce, MD at Columbia University. The trial plans to enroll 6 participants.