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NCT03154996

Chronic Convection Enhanced Delivery of Topotecan

Completed Phase 1 Last updated 5 July 2022
What this trial tests

Phase 1 trial testing Topotecan in Gliomas in 5 participants. Completed in 20 August 2021.

Timeline
18 January 2018
Primary endpoint
20 August 2021
20 August 2021

Quick facts

Lead sponsorJeffrey N. Bruce
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date18 January 2018
Primary completion20 August 2021
Estimated completion20 August 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. Breaching the Blood-Brain Tumor Barrier for Tumor Therapy.
    Marcucci F, Corti A, Ferreri AJM. · · 2021 · cited 30× · PMID 34063335 · DOI 10.3390/cancers13102391
  5. 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
  6. Convection-enhanced delivery for high-grade glioma.
    Kang JH, Desjardins A. · · 2022 · cited 21× · PMID 35096401 · DOI 10.1093/nop/npab065
  7. 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
  8. 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

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