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NCT03154996
Chronic Convection Enhanced Delivery of Topotecan
Phase 1 trial testing Topotecan in Gliomas in 5 participants. Completed in 20 August 2021.
20 August 2021
Quick facts
| Lead sponsor | Jeffrey N. Bruce |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 18 January 2018 |
| Primary completion | 20 August 2021 |
| Estimated completion | 20 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Topotecan (topotecan) — full drug profile →
- Gadolinium (GADOLINIUM) — full drug profile →
- Synchromed II infusion pumps
Conditions studied
- Gliomas — all drugs for Gliomas →
Sponsor
Jeffrey N. Bruce
Who can join
18 and older, any sex, with Gliomas. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary goal of this study is to establish, for the first time, safety of prolonged intracerebral convection enhanced delivery of chemotherapy in patients with recurrent high grade glioma (HGG). Secondary objectives will include determination of topotecan (TPT) distribution and radiographic tumor response with prolonged continuous intracerebral convection-enhanced delivery (CED).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Convection-enhanced drug delivery for glioblastoma: a review.
D'Amico RS, Aghi MK, Vogelbaum MA, Bruce JN. · · 2021 · cited 116× · PMID 33611708 · DOI 10.1007/s11060-020-03408-9 -
Chronic convection-enhanced delivery of topotecan for patients with recurrent glioblastoma: a first-in-patient, single-centre, single-arm, phase 1b trial.
Spinazzi EF, Argenziano MG, Upadhyayula PS, Banu MA, et al · · 2022 · cited 66× · PMID 36243020 · DOI 10.1016/s1470-2045(22)00599-x -
Addressing BBB Heterogeneity: A New Paradigm for Drug Delivery to Brain Tumors.
Griffith JI, Rathi S, Zhang W, Zhang W, et al · · 2020 · cited 47× · PMID 33322488 · DOI 10.3390/pharmaceutics12121205 -
Breaching the Blood-Brain Tumor Barrier for Tumor Therapy.
Marcucci F, Corti A, Ferreri AJM. · · 2021 · cited 30× · PMID 34063335 · DOI 10.3390/cancers13102391 -
Research progress of anti-glioma chemotherapeutic drugs (Review).
Zhou YS, Wang W, Chen N, Wang LC, et al · · 2022 · cited 23× · PMID 35362540 · DOI 10.3892/or.2022.8312 -
Convection-enhanced delivery for high-grade glioma.
Kang JH, Desjardins A. · · 2022 · cited 21× · PMID 35096401 · DOI 10.1093/nop/npab065 -
Convection Enhanced Delivery in the Setting of High-Grade Gliomas.
Nwagwu CD, Immidisetti AV, Jiang MY, Adeagbo O, et al · · 2021 · cited 15× · PMID 33921157 · DOI 10.3390/pharmaceutics13040561 -
Anatomical Targeting of Anticancer Drugs to Solid Tumors Using Specific Administration Routes: Review.
Saito A, Kitayama J, Nagai R, Aizawa K. · · 2023 · cited 11× · PMID 37376112 · DOI 10.3390/pharmaceutics15061664
Verify or expand the search:
- PubMed search for NCT03154996
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Gliomas
Currently open trials in the same condition.
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- NCT06828341 — A Single-arm, Open, Exploratory Clinical Study of Allogeneic CAR-T Cells in the Treatment of Relapsed/Refractory Brain G · EARLY_PHASE1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03154996 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jeffrey N. Bruce
- Last refreshed: 5 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03154996.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing