NCT01851733

MRI-Guided Laser Surgery and Doxorubicin Hydrochloride in Treating Patients With Recurrent Glioblastoma Multiforme

Completed Phase 1 Last updated 27 August 2021

What this trial tests

Phase 1 trial testing MRI-guided Laser Heat Ablation (MLA) in Glioblastoma in 37 participants. Completed in 30 May 2018.

Timeline

13 August 2013

Primary endpoint
12 April 2018

30 May 2018

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	37
Start date	13 August 2013
Primary completion	12 April 2018
Estimated completion	30 May 2018
Sites	1 location across United States

Drugs / interventions tested

• MRI-guided Laser Heat Ablation (MLA)
• Doxorubicin (doxorubicin) — full drug profile →
• Blood draw - dendritic cells
• Dynamic Susceptibility Contrast Magnetic Resonance Imaging

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot clinical trial studies magnetic resonance imaging (MRI)-guided laser surgery (MLA) and doxorubicin hydrochloride in treating patients with recurrent glioblastoma multiforme. The blood brain barrier (BBB) is a separation of circulating blood from the tissue of the central nervous system, preventing substances in the blood from entering the brain. MLA disrupts the BBB around the tumor which may allow cancer-killing substances to be carried directly to the tumor and the surrounding area. Using MLA prior to chemotherapy may result in a greater concentration of drug in the tumor to kill the cancer cells while limiting side effects.

Publications & conference data

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

1. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
2. Hyperthermic Laser Ablation of Recurrent Glioblastoma Leads to Temporary Disruption of the Peritumoral Blood Brain Barrier.
   Leuthardt EC, Duan C, Kim MJ, Campian JL, et al · · 2016 · cited 147× · PMID 26910903 · DOI 10.1371/journal.pone.0148613
3. Trial Watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Aranda F, Eggermont A, Galon J, et al · · 2014 · cited 123× · PMID 24800173 · DOI 10.4161/onci.27878
4. Challenges and opportunities to penetrate the blood-brain barrier for brain cancer therapy.
   Upton DH, Ung C, George SM, Tsoli M, et al · · 2022 · cited 96× · PMID 35832071 · DOI 10.7150/thno.69682
5. Glioblastoma Treatments: An Account of Recent Industrial Developments.
   Alphandéry E. · · 2018 · cited 73× · PMID 30271342 · DOI 10.3389/fphar.2018.00879
6. Blood-Brain Barrier Disruption in Neuro-Oncology: Strategies, Failures, and Challenges to Overcome.
   Karmur BS, Philteos J, Abbasian A, Zacharia BE, et al · · 2020 · cited 58× · PMID 33072591 · DOI 10.3389/fonc.2020.563840
7. Therapeutic enhancement of blood-brain and blood-tumor barriers permeability by laser interstitial thermal therapy.
   Salehi A, Paturu MR, Patel B, Cain MD, et al · · 2020 · cited 58× · PMID 32666049 · DOI 10.1093/noajnl/vdaa071
8. Laser ablation: Heating up the anti-tumor response in the intracranial compartment.
   Lerner EC, Edwards RM, Wilkinson DS, Fecci PE. · · 2022 · cited 50× · PMID 35489652 · DOI 10.1016/j.addr.2022.114311