FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3022566363> ?p ?o ?g. }

• W3022566363 abstract "Introduction: We present a novel autologous cell vaccine therapy designed to treat patients with newly diagnosed glioblastoma (Trial Registration: IND 14379, NCT01550523). Methods: This phase 1b trial has a phase 2 design with 4 randomized vaccine dose cohorts in 33 patients with the objective being safety assessment but also including clinical, radiographic, and immune analyses. Eligibility criteria included age > 18 and Karnofsky score of > 60; neither bihemispheric disease nor extent of resection were exclusion criteria but autoimmune diseases were. During craniotomy for tumor resection, if frozen section confirmed GBM, incisions were made in the lower abdomen through the rectus sheath and pockets created between the sheath and the muscle and the wounds closed with a temporary three-layer closure. Tumor resection involved an aspirator that collected morselized viable tumor tissue in sterile traps. The tissue was processed by overnight culture with 0.2 mg of an IGF-1R antisense oligodeoxynucleotide/gm. The next (first postoperative) day, treated tumor cells were harvested, encapsulated in either ten or twenty small biodiffusion chambers along with 4 micrograms of the IGF-1R antisense, irradiated and then implanted at bedside in the abdominal acceptor sites as previously described (1). Chambers were explanted 24 or 48 hours later, depending on randomization. Standard of care according to Stupp (2) was initiated at 6 weeks. Studies included 3T MRI imaging and analysis of serial blood samples for T cell function and cytokine levels. Disease progression was assessed using RANO (3) and iRANO (4) criteria with a data cutoff of March 1 (N=30) used for this analysis. Results: The trial opened September 1, 2015 and completed accrual on March 1, 2018. A midpoint interim analysis revealed significantly more robust cytokine responses at the highest vaccine dose. Randomization was therefore stopped at subject 23 and amended to treat using only the highest dose. Progression-free survival (PFS) was compared to three historic SOC comparators (Stupp [2], Kong [5], and an antecedent cohort of 37 consecutive patients treated with SOC at our institution [TJUH]). PFS was significantly improved at 10.5 mo v. SOC comparators: 6.9 mo (Stupp, p = .003), 5.3 mo (Kong, p = .002) and 7 mo (TJUH, p = .013). Seventy-five percent of the 14 patients in the highest-dose cohort had robust proinflammatory and early evidence of sustained immune reactivity associated with tumor regression or no recurrence after surgery. Conclusion: These data reflect a therapeutic benefit defined as significant improvement in PFS without increased safety risk compared to three different SOC cohorts. Since GBM remains one of the most challenging solid tumors, this treatment design invites investigator collaboration in a multicenter phase 2 trial. References: 1. Andrew et al. J Clin Oncol 19:2189-2200; 2. Stupp et al. NEJM 352:987-96; 3. Wen et al. J Clin. Oncol 28:1963-72; 4. Okada et al. Lancet Oncol 16:534-42; 5. Kong et al. Oncotarget 8:7003-13. Citation Format: Kevin D. Judy, David W. Andrews, Larry Harshyne, Lawrence Kenyon, Kiran Talekar, Kofi-Buaku Atsina, Lyndon Kim, Wenyin Shi, Maria Werner-Wasik, Rhonda Kean, Samantha Garcia, Kara Pigott, Charles B. Scott, D. Craig Hooper. Phase 1b/2 prospective randomized trial of four autologous cell vaccine dose cohorts for initial treatment of glioblastoma [abstract]. In: Proceedings of the AACR Special Conference on Tumor Immunology and Immunotherapy; 2018 Nov 27-30; Miami Beach, FL. Philadelphia (PA): AACR; Cancer Immunol Res 2020;8(4 Suppl):Abstract nr B71." @default.
• W3022566363 created "2020-05-13" @default.
• W3022566363 creator A5001776552 @default.
• W3022566363 creator A5014352993 @default.
• W3022566363 creator A5016048962 @default.
• W3022566363 creator A5030653008 @default.
• W3022566363 creator A5032582522 @default.
• W3022566363 creator A5038036095 @default.
• W3022566363 creator A5043541849 @default.
• W3022566363 creator A5045868163 @default.
• W3022566363 creator A5059909608 @default.
• W3022566363 creator A5062905847 @default.
• W3022566363 creator A5064811472 @default.
• W3022566363 creator A5066158171 @default.
• W3022566363 creator A5086655595 @default.
• W3022566363 creator A5090187344 @default.
• W3022566363 date "2020-04-01" @default.
• W3022566363 modified "2023-09-26" @default.
• W3022566363 title "Abstract B71: Phase 1b/2 prospective randomized trial of four autologous cell vaccine dose cohorts for initial treatment of glioblastoma" @default.
• W3022566363 doi "https://doi.org/10.1158/2326-6074.tumimm18-b71" @default.
• W3022566363 hasPublicationYear "2020" @default.
• W3022566363 type Work @default.
• W3022566363 sameAs 3022566363 @default.
• W3022566363 citedByCount "0" @default.
• W3022566363 crossrefType "proceedings-article" @default.
• W3022566363 hasAuthorship W3022566363A5001776552 @default.
• W3022566363 hasAuthorship W3022566363A5014352993 @default.
• W3022566363 hasAuthorship W3022566363A5016048962 @default.
• W3022566363 hasAuthorship W3022566363A5030653008 @default.
• W3022566363 hasAuthorship W3022566363A5032582522 @default.
• W3022566363 hasAuthorship W3022566363A5038036095 @default.
• W3022566363 hasAuthorship W3022566363A5043541849 @default.
• W3022566363 hasAuthorship W3022566363A5045868163 @default.
• W3022566363 hasAuthorship W3022566363A5059909608 @default.
• W3022566363 hasAuthorship W3022566363A5062905847 @default.
• W3022566363 hasAuthorship W3022566363A5064811472 @default.
• W3022566363 hasAuthorship W3022566363A5066158171 @default.
• W3022566363 hasAuthorship W3022566363A5086655595 @default.
• W3022566363 hasAuthorship W3022566363A5090187344 @default.
• W3022566363 hasConcept C121608353 @default.
• W3022566363 hasConcept C126322002 @default.
• W3022566363 hasConcept C141071460 @default.
• W3022566363 hasConcept C168563851 @default.
• W3022566363 hasConcept C2776694085 @default.
• W3022566363 hasConcept C2777389519 @default.
• W3022566363 hasConcept C2777701055 @default.
• W3022566363 hasConcept C2908973413 @default.
• W3022566363 hasConcept C535046627 @default.
• W3022566363 hasConcept C71924100 @default.
• W3022566363 hasConceptScore W3022566363C121608353 @default.
• W3022566363 hasConceptScore W3022566363C126322002 @default.
• W3022566363 hasConceptScore W3022566363C141071460 @default.
• W3022566363 hasConceptScore W3022566363C168563851 @default.
• W3022566363 hasConceptScore W3022566363C2776694085 @default.
• W3022566363 hasConceptScore W3022566363C2777389519 @default.
• W3022566363 hasConceptScore W3022566363C2777701055 @default.
• W3022566363 hasConceptScore W3022566363C2908973413 @default.
• W3022566363 hasConceptScore W3022566363C535046627 @default.
• W3022566363 hasConceptScore W3022566363C71924100 @default.
• W3022566363 hasLocation W30225663631 @default.
• W3022566363 hasOpenAccess W3022566363 @default.
• W3022566363 hasPrimaryLocation W30225663631 @default.
• W3022566363 hasRelatedWork W11390353 @default.
• W3022566363 hasRelatedWork W12841072 @default.
• W3022566363 hasRelatedWork W158596 @default.
• W3022566363 hasRelatedWork W16180300 @default.
• W3022566363 hasRelatedWork W3468639 @default.
• W3022566363 hasRelatedWork W3582852 @default.
• W3022566363 hasRelatedWork W3715887 @default.
• W3022566363 hasRelatedWork W6125740 @default.
• W3022566363 hasRelatedWork W6961521 @default.
• W3022566363 hasRelatedWork W8404377 @default.
• W3022566363 isParatext "false" @default.
• W3022566363 isRetracted "false" @default.
• W3022566363 magId "3022566363" @default.
• W3022566363 workType "article" @default.