OncoMatch/Clinical Trials/NCT06666712
Chronic CED of TPT for Recurrent Malignant Glioma
Is NCT06666712 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Topotecan for brain tumor, recurrent.
Treatment: Topotecan — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Required: IDH2 mutation
Disease stage
Required: Stage WHO GRADE 3, WHO GRADE 4 (WHO)
Excluded: Stage WHO GRADE 2 WITHOUT HIGH-GRADE FEATURES
Grade: 34 (WHO)
WHO grade 3-4 IDH-mutant status
Prior therapy
Must have received: standard of care treatment
Patients with recurrent malignant glioma, IDH-mutant, who have failed standard of care treatment are eligible.
Cannot have received: topoisomerase inhibitor (topotecan)
Patients who have previously received systemic topotecan for their tumor.
Lab requirements
Blood counts
Leukocytes: ≥3,000/mcL; Absolute neutrophil count: ≥1,500/mcL; Platelets: ≥100,000/mcL
Kidney function
Creatinine: within normal institutional limits OR Creatinine clearance: ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Liver function
Total bilirubin: within normal institutional limits; AST(SGOT)/ALT(SGPT): ≤2.5 × institutional upper limit of normal
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital · New York, New York
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