NCT05271240

Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM

Recruiting now Phase 3 Last updated 19 September 2024

What this trial tests

Phase 3 trial testing Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation in Glioblastoma in 432 participants. Currently enrolling.

Timeline

27 April 2022

Primary endpoint
1 April 2027

1 April 2028

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	432
Start date	27 April 2022
Primary completion	1 April 2027
Estimated completion	1 April 2028
Sites	1 location across United States

Drugs / interventions tested

• Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation
• Temozolomide and Radiation Alone — full drug profile →

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →
• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
• Glioma, Malignant — all drugs for Glioma, Malignant →
• GBM — all drugs for GBM →

Sponsor

Northwell Health — full company profile →

Who can join

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

Sponsor's own description

Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology.

The investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg/kg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I/II clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.

Publications & conference data

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

1. Breaking Barriers in Neuro-Oncology: A Scoping Literature Review on Invasive and Non-Invasive Techniques for Blood-Brain Barrier Disruption.
   Pinkiewicz M, Pinkiewicz M, Walecki J, Zaczyński A, et al · · 2024 · cited 24× · PMID 38201663 · DOI 10.3390/cancers16010236
2. A systematic review on intra-arterial cerebral infusions of chemotherapeutics in the treatment of glioblastoma multiforme: The state-of-the-art.
   Pinkiewicz M, Pinkiewicz M, Walecki J, Zawadzki M. · · 2022 · cited 21× · PMID 36212394 · DOI 10.3389/fonc.2022.950167
3. Angiogenesis in Glioblastoma-Treatment Approaches.
   Nowacka A, Śniegocki M, Smuczyński W, Bożiłow D, et al · · 2025 · cited 20× · PMID 40136656 · DOI 10.3390/cells14060407
4. Consensus review on strategies to improve delivery across the blood-brain barrier including focused ultrasound.
   Piper K, Kumar JI, Domino J, Tuchek C, et al · · 2024 · cited 15× · PMID 38770775 · DOI 10.1093/neuonc/noae087
5. Mechanistic insights and the clinical prospects of targeted therapies for glioblastoma: a comprehensive review.
   Shen Y, Thng DKH, Wong ALA, Toh TB. · · 2024 · cited 12× · PMID 38615034 · DOI 10.1186/s40164-024-00512-8
6. Endovascular Applications for the Management of High-Grade Gliomas in the Modern Era.
   Kappel AD, Jha R, Guggilapu S, Smith WJ, et al · · 2024 · cited 9× · PMID 38672676 · DOI 10.3390/cancers16081594
7. Therapeutic manipulation and bypass of the blood-brain barrier: powerful tools in glioma treatment.
   Giantini-Larsen AM, Pandey A, Garton ALA, Rampichini M, et al · · 2025 · cited 8× · PMID 39877748 · DOI 10.1093/noajnl/vdae201
8. Comprehensive Molecular Genetic Analysis in Glioma Patients by Next Generation Sequencing.
   Kim T, Lee A, Ahn S, Park JS, et al · · 2024 · cited 8× · PMID 38317486 · DOI 10.14791/btrt.2023.0036