NCT02278510

Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma

Completed EARLY_PHASE1 Last updated 31 March 2017

What this trial tests

EARLY_PHASE1 trial testing Topotecan in Malignant Glioma in 3 participants. Completed in 10 November 2015.

Timeline

9 December 2014

Primary endpoint
10 November 2015

10 November 2015

Quick facts

Lead sponsor	Michael Vogelbaum, MD, PhD
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	9 December 2014
Primary completion	10 November 2015
Estimated completion	10 November 2015
Sites	1 location across United States

Drugs / interventions tested

• Topotecan (topotecan) — full drug profile →
• Gadolinium DTPA — full drug profile →
• Cleveland Multiport Catheter

Conditions studied

• Malignant Glioma — all drugs for Malignant Glioma →
• WHO Grade III or IV Recurrent Glioma — all drugs for WHO Grade III or IV Recurrent Glioma →

Sponsor

Michael Vogelbaum, MD, PhD — full company profile →

Who can join

18 and older, any sex, with Malignant Glioma or WHO Grade III or IV Recurrent Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan directly into participants' brain tumors. One purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan directly into brain tumors. This study will also evaluate different doses of topotecan that can be delivered to a participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also examine how their tumor responds to treatment with topotecan.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Convection-Enhanced Delivery.
   Mehta AM, Sonabend AM, Bruce JN. · · 2017 · cited 205× · PMID 28299724 · DOI 10.1007/s13311-017-0520-4
2. Promising approaches to circumvent the blood-brain barrier: progress, pitfalls and clinical prospects in brain cancer.
   Papademetriou IT, Porter T. · · 2015 · cited 49× · PMID 26488496 · DOI 10.4155/tde.15.48
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. Nanotherapeutic systems for local treatment of brain tumors.
   Chakroun RW, Zhang P, Lin R, Schiapparelli P, et al · · 2018 · cited 45× · PMID 28544801 · DOI 10.1002/wnan.1479
5. First-in-human evaluation of the Cleveland Multiport Catheter for convection-enhanced delivery of topotecan in recurrent high-grade glioma: results of pilot trial 1.
   Vogelbaum MA, Brewer C, Barnett GH, Mohammadi AM, et al · · 2019 · cited 42× · PMID 29652233 · DOI 10.3171/2017.10.jns171845
6. Convection-Enhanced Delivery of a First-in-Class Anti-β1 Integrin Antibody for the Treatment of High-Grade Glioma Utilizing Real-Time Imaging.
   Nwagwu CD, Immidisetti AV, Bukanowska G, Vogelbaum MA, et al · · 2020 · cited 31× · PMID 33396712 · DOI 10.3390/pharmaceutics13010040
7. Breaching the Blood-Brain Tumor Barrier for Tumor Therapy.
   Marcucci F, Corti A, Ferreri AJM. · · 2021 · cited 30× · PMID 34063335 · DOI 10.3390/cancers13102391
8. Therapeutic Targeting of Stat3 Using Lipopolyplex Nanoparticle-Formulated siRNA in a Syngeneic Orthotopic Mouse Glioma Model.
   Linder B, Weirauch U, Ewe A, Uhmann A, et al · · 2019 · cited 25× · PMID 30857197 · DOI 10.3390/cancers11030333