Actively Recruiting
Chronic CED of TPT for Recurrent Malignant Glioma
Led by Jeffrey N. Bruce · Updated on 2026-04-15
6
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Chronic CED of TPT for Recurrent Malignant Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have recurrent malignant glioma with WHO grade 3-4 IDH-mutant status and evidence of tumor progression.
- Patients with prior WHO grade 2 recurrent glioma who now show high-grade features of IDH-mutant WHO grade 3-4 are eligible.
- Patients must have failed standard of care treatment for recurrent malignant glioma.
- MRI scan within 30 days before enrollment showing an enhancing tumor mass less than 32 cc in volume.
- Tumor must be accessible for stereotactic biopsy.
- Karnofsky performance score must be 70 or higher.
- Men and women of childbearing potential must use birth control; women must have a urine pregnancy test within 7 days before study entry.
- Women must continue birth control for at least 1 month after chemotherapy; men must continue for 4 months after chemotherapy.
- Patients or legal representatives must be able to give informed consent.
- Patients must be willing and medically able to undergo surgery.
- Patients must be at least 18 years old.
- Normal organ and marrow function within 14 days before registration, including specific blood counts and kidney and liver function requirements.
You will not qualify if you...
- Patients with diffuse subependymal or cerebrospinal fluid disease.
- Tumors involving the cerebellum or both cerebral hemispheres.
- Active infections requiring treatment or unexplained fever.
- Known HIV, Hepatitis B, or Hepatitis C positive status; HIV-positive patients on combination therapy are excluded.
- Systemic diseases posing unacceptable risks for anesthesia or surgery.
- Prior systemic treatment with Topotecan.
- Inability to undergo MRI or PET scans.
- Allergy to Topotecan, other topoisomerase inhibitors, or gadolinium compounds.
- Current treatment with certain medications affecting CYP enzymes or with risk of QT prolongation.
- Uncontrolled illnesses such as severe heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting study compliance.
- Women of childbearing potential with a positive pregnancy test within 7 days before registration.
- Women who are breastfeeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Jeffrey Bruce, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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