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Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment.

Author: AbediMehrdad, AikenRobert D, BotaDaniela A, BotaPeter G, CarrilloJose A, DillmanRobert O, DumaChristopher M, HsiehCandace, HsuFrank P K, KeirsteadHans S, KesariSantosh, KongXiao-Tang, LaRoccaRenato V, NistorGabriel I, PiccioniDavid E, TaylorThomas H

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Overview

The Aivita GBM vaccine (AV-GBM-1) was reliably manufactured and well-tolerated, but there were numerous treatment-emergent central nervous system adverse events. This multicenter phase II trial showed a 97% success rate for both TIC production and monocyte collection. The most common adverse events were local injection site reactions (16%) and flu-like symptoms (10%). Median Progression-Free Survival (mPFS) was 10.4 months and median Overall Survival (mOS) was 16.0 months.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Vaccine immunotherapy may improve survival in Glioblastoma (GBM). A multicenter phase II trial was designed to determine: (1) the success rate of manufacturing the Aivita GBM vaccine (AV-GBM-1), (2) Adverse Events (AE) associated with AV-GBM-1 administration, and (3) survival. METHODS: ...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9749349/

データ提供：米国国立医学図書館（NLM）

AV-GBM-1: A Potential Oasis in the Desert of Glioblastoma Treatment

Glioblastoma (GBM), a formidable desert storm in the world of cancer, is a highly aggressive and difficult-to-treat brain tumor. This phase II study investigated the safety and efficacy of AV-GBM-1, a tumor-initiating cell targeted dendritic cell vaccine, as a potential oasis in the desert of GBM treatment. The researchers conducted a multicenter trial with 63 patients, carefully evaluating the safety and survival outcomes associated with AV-GBM-1 administration. While no significant improvement in overall survival was observed, the study provides encouraging evidence for AV-GBM-1's safety and potential to improve progression-free survival. This research underscores the need for continued exploration of novel immunotherapies in the fight against GBM.

AV-GBM-1: A Glimpse of Hope in the Desert of Glioblastoma

This phase II study suggests that AV-GBM-1 is a safe and potentially promising treatment option for GBM. While further research is needed to confirm its effectiveness, the results indicate that it may be a valuable addition to the existing arsenal of GBM treatments. This research adds to the growing body of evidence supporting the exploration of immunotherapies in cancer treatment.

Navigating the Sands of Glioblastoma Treatment

Glioblastoma is a challenging and often devastating disease. This study highlights the need for continued research and development of novel therapies, such as immunotherapies like AV-GBM-1. It encourages clinicians to stay abreast of the latest advances in GBM treatment and explore all available options for their patients.

Dr. Camel's Conclusion

This phase II study offers a glimpse of hope in the desert of glioblastoma treatment. While further research is necessary to fully assess its effectiveness, AV-GBM-1 emerges as a potential oasis, offering a safe and potentially promising treatment option for patients with this aggressive disease.

Date :
  1. Date Completed 2022-12-20
  2. Date Revised 2023-04-13
Further Info :

Pubmed ID

36517865

DOI: Digital Object Identifier

PMC9749349

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English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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