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Robert O. Dillman - One of the best experts on this subject based on the ideXlab platform.
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Cytokine network analysis of immune responses before and after autologous dendritic Cell and Tumor Cell Vaccine immunotherapies in a randomized trial
Journal of translational medicine, 2020Co-Authors: Gabriel Nistor, Robert O. DillmanAbstract:In a randomized phase II trial conducted in patients with metastatic melanoma, patient-specific autologous dendritic Cell Vaccines (DCV) were associated with longer survival than autologous Tumor Cell Vaccines (TCV). Both Vaccines presented antigens from Cell-renewing autologous Tumor Cells. The current analysis was performed to better understand the immune responses induced by these Vaccines, and their association with survival. 110 proteomic markers were measured at a week-0 baseline, 1 week before the first of 3 weekly Vaccine injections, and at week-4, 1 week after the third injection. Data was presented as a deviation from normal controls. A two-component principal component (PC) statistical analysis and discriminant analysis were performed on this data set for all patients and for each treatment cohort. At baseline PC-1 contained 64.4% of the variance and included the majority of cytokines associated with Th1 and Th2 responses, which positively correlated with beta-2-microglobulin (B2M), programmed death protein-1 (PD-1) and transforming growth factor beta (TGFβ1). Results were similar at baseline for both treatment cohorts. After three injections, DCV-treated patients showed correlative grouping among Th1/Th17 cytokines on PC-1, with an inverse correlation with B2M, FAS, and IL-18, and correlations among immunoglobulins in PC-2. TCV-treated patients showed a positive correlation on PC-1 among most of the cytokines and Tumor markers B2M and FAS receptor. There were also correlative changes of IL12p40 with both Th1 and Th2 cytokines and TGFβ1. Discriminant analysis provided additional evidence that DCV was associated with innate, Th1/Th17, and Th2 responses while TCV was only associated with innate and Th2 responses. These analyses confirm that DCV induced a different immune response than that induced by TCV, and these immune responses were associated with improved survival. Trial registration Clinical trials.gov NCT004936930 retrospectively registered 28 July 2009
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High-dose IL-2 in metastatic melanoma: better survival in patients who also received patient-specific autologous Tumor Cell Vaccine
Journal for ImmunoTherapy of Cancer, 2013Co-Authors: Robert O. Dillman, Carol Depriest, Stephanie E. McclureAbstract:Treatment with high-dose Interleukin-2 (IL-2) has been associated with long-term survival in small proportion of metastatic melanoma patients. We recently reported a median survival of 15.6 months, and a 20% 5-year survival rate for 150 such patients who were hospitalized for high-dose i.v. IL-2 between May 1987 and April 2010. [1] A recent report showed a survival advantage for the addition of gp100 Vaccine plus high-dose IL-2 compared to treatment with IL-2 alone [2]. We were aware that several of our IL-2 patients had also received patient-specific Tumor Cell Vaccines derived from autologous Tumor Cell lines. We wished to determine whether this may have contributed to their high 5-year survival rate. Comparison of existing data bases revealed that 27 of the 150 IL-2 patients had also received a patient-specific Vaccine; 123 had not. The table below (Table (Table1)1) summarizes survival data, which was calculated from the date IL-2 was initiated. Survival was much better in patients who received a patient-specific Vaccine in addition to IL-2 (p age of 50 (NSD). Of the 27 Vaccine patients, 7 started Vaccine therapy an average of 8.7 mos. before receiving IL-2 (range 2.4 to 40 mos.) and 20 received Vaccine a median of 14.2 months after starting IL-2 (range 1 to 42 mos.); 12 received injections of irradiated autologous Tumor Cells and 15 received injections of dendritic Cells loaded with antigens from irradiated autologous Tumor Cells, and suspended in 500 microgram GM-CSF. Survival was longer in patients who received IL-2 first (5-yr survival 55% vs 14%), and in patients who received the dendritic Cell Vaccine (5-yr survival 53% vs 33%). This analysis suggests that receipt of high-dose IL-2 followed by a patient specific Vaccine results in better survival than IL-2 alone, but the limitations of such a retrospective analysis, and the risk of confounding unintended bias, are significant. Table 1
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phase ii study of belagenpumatucel l a transforming growth factor beta 2 antisense gene modified allogeneic Tumor Cell Vaccine in non small Cell lung cancer
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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phase ii study of belagenpumatucel l a transforming growth factor beta 2 antisense gene modified allogeneic Tumor Cell Vaccine in non small Cell lung cancer
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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Phase II Study of Belagenpumatucel-L, a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine in Non–Small-Cell Lung Cancer
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
D L Shawler - One of the best experts on this subject based on the ideXlab platform.
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Phase I clinical trial of a TGF-β antisense-modified Tumor Cell Vaccine in patients with advanced glioma
Cancer Gene Therapy, 2006Co-Authors: H Fakhrai, J C Mantil, L Liu, G L Nicholson, C S Murphy-satter, J Ruppert, D L ShawlerAbstract:We performed a phase I clinical trial in grade IV astrocytoma to assess the safety of a whole-Cell Vaccine comprising autologous Tumor Cells genetically modified by a transforming growth factor- β 2 (TGF- β 2) antisense vector. Blocking secretion of the immunosuppressive molecule TGF- β in this manner should inhibit one of the major mechanisms by which Tumor Cells evade immune surveillance and should lead to clinically effective antiTumor immunity. Six patients with progressive WHO grade IV astrocytoma were enrolled in the trial. Patients received 2–7 subcutaneous injections of 5 × 10^6–2 × 10^7 autologous Tumor Cells per injection. TGF- β 2 secretion by the Tumor Cells used to vaccinate patients was inhibited by 53–98%. Treatment was well tolerated with only low-grade, transient treatment-related toxicities reported. Two patients had partial regressions and two had stable disease following therapy. The overall median survival was 68 weeks. Median survival of the responding patients was 78 weeks, compared to a historic value of 47 weeks for glioma patients treated conventionally. There were indications of humoral and Cellular immunity induced by the Vaccine. These findings support further clinical evaluation of Vaccines comprised of TGF- β antisense-modified Tumor Cells.
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Phase I clinical trial of a TGF-beta antisense-modified Tumor Cell Vaccine in patients with advanced glioma.
Cancer gene therapy, 2006Co-Authors: H Fakhrai, J C Mantil, L Liu, G L Nicholson, C S Murphy-satter, J Ruppert, D L ShawlerAbstract:We performed a phase I clinical trial in grade IV astrocytoma to assess the safety of a whole-Cell Vaccine comprising autologous Tumor Cells genetically modified by a transforming growth factor-beta2 (TGF-beta2) antisense vector. Blocking secretion of the immunosuppressive molecule TGF-beta in this manner should inhibit one of the major mechanisms by which Tumor Cells evade immune surveillance and should lead to clinically effective antiTumor immunity. Six patients with progressive WHO grade IV astrocytoma were enrolled in the trial. Patients received 2-7 subcutaneous injections of 5 x 10(6)-2 x 10(7) autologous Tumor Cells per injection. TGF-beta2 secretion by the Tumor Cells used to vaccinate patients was inhibited by 53-98%. Treatment was well tolerated with only low-grade, transient treatment-related toxicities reported. Two patients had partial regressions and two had stable disease following therapy. The overall median survival was 68 weeks. Median survival of the responding patients was 78 weeks, compared to a historic value of 47 weeks for glioma patients treated conventionally. There were indications of humoral and Cellular immunity induced by the Vaccine. These findings support further clinical evaluation of Vaccines comprised of TGF-beta antisense-modified Tumor Cells.
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Phase II study of a TGF-{beta}2 antisense gene modified allogeneic Tumor Cell Vaccine (Lucanix) in advanced NSCLC
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, D L Shawler, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Edward Devol, Terry Chamberlin, H FakhraiAbstract:7018 Background: Lucanix (L) is a non-viral gene based allogeneic Tumor Cell Vaccine which demonstrates enhancement of Tumor antigen recognition as a result of Transforming Growth Factor (TGF-β2) i...
H Fakhrai - One of the best experts on this subject based on the ideXlab platform.
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Phase I clinical trial of a TGF-β antisense-modified Tumor Cell Vaccine in patients with advanced glioma
Cancer Gene Therapy, 2006Co-Authors: H Fakhrai, J C Mantil, L Liu, G L Nicholson, C S Murphy-satter, J Ruppert, D L ShawlerAbstract:We performed a phase I clinical trial in grade IV astrocytoma to assess the safety of a whole-Cell Vaccine comprising autologous Tumor Cells genetically modified by a transforming growth factor- β 2 (TGF- β 2) antisense vector. Blocking secretion of the immunosuppressive molecule TGF- β in this manner should inhibit one of the major mechanisms by which Tumor Cells evade immune surveillance and should lead to clinically effective antiTumor immunity. Six patients with progressive WHO grade IV astrocytoma were enrolled in the trial. Patients received 2–7 subcutaneous injections of 5 × 10^6–2 × 10^7 autologous Tumor Cells per injection. TGF- β 2 secretion by the Tumor Cells used to vaccinate patients was inhibited by 53–98%. Treatment was well tolerated with only low-grade, transient treatment-related toxicities reported. Two patients had partial regressions and two had stable disease following therapy. The overall median survival was 68 weeks. Median survival of the responding patients was 78 weeks, compared to a historic value of 47 weeks for glioma patients treated conventionally. There were indications of humoral and Cellular immunity induced by the Vaccine. These findings support further clinical evaluation of Vaccines comprised of TGF- β antisense-modified Tumor Cells.
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Phase I clinical trial of a TGF-beta antisense-modified Tumor Cell Vaccine in patients with advanced glioma.
Cancer gene therapy, 2006Co-Authors: H Fakhrai, J C Mantil, L Liu, G L Nicholson, C S Murphy-satter, J Ruppert, D L ShawlerAbstract:We performed a phase I clinical trial in grade IV astrocytoma to assess the safety of a whole-Cell Vaccine comprising autologous Tumor Cells genetically modified by a transforming growth factor-beta2 (TGF-beta2) antisense vector. Blocking secretion of the immunosuppressive molecule TGF-beta in this manner should inhibit one of the major mechanisms by which Tumor Cells evade immune surveillance and should lead to clinically effective antiTumor immunity. Six patients with progressive WHO grade IV astrocytoma were enrolled in the trial. Patients received 2-7 subcutaneous injections of 5 x 10(6)-2 x 10(7) autologous Tumor Cells per injection. TGF-beta2 secretion by the Tumor Cells used to vaccinate patients was inhibited by 53-98%. Treatment was well tolerated with only low-grade, transient treatment-related toxicities reported. Two patients had partial regressions and two had stable disease following therapy. The overall median survival was 68 weeks. Median survival of the responding patients was 78 weeks, compared to a historic value of 47 weeks for glioma patients treated conventionally. There were indications of humoral and Cellular immunity induced by the Vaccine. These findings support further clinical evaluation of Vaccines comprised of TGF-beta antisense-modified Tumor Cells.
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Phase II study of a TGF-{beta}2 antisense gene modified allogeneic Tumor Cell Vaccine (Lucanix) in advanced NSCLC
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, D L Shawler, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Edward Devol, Terry Chamberlin, H FakhraiAbstract:7018 Background: Lucanix (L) is a non-viral gene based allogeneic Tumor Cell Vaccine which demonstrates enhancement of Tumor antigen recognition as a result of Transforming Growth Factor (TGF-β2) i...
Neil Senzer - One of the best experts on this subject based on the ideXlab platform.
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phase i trial of bi shrnaifurin gmcsf dna autologous Tumor Cell Vaccine fang in advanced cancer
Molecular Therapy, 2012Co-Authors: Neil Senzer, Minal Barve, Joseph A Kuhn, Anton Melnyk, Peter Beitsch, Martin Lazar, Samuel Lifshitz, Mitchell Magee, Jonathan Oh, Susan W MillAbstract:We performed a phase I trial of FANG Vaccine, an autologous Tumor-based product incorporating a plasmid encoding granulocyte-macrophage colony-stimulating factor (GMCSF) and a novel bifunctional short hairpin RNAi (bi-shRNAi) targeting furin convertase, thereby downregulating endogenous immunosuppressive transforming growth factors (TGF) β1 and β2. Patients with advanced cancer received up to 12 monthly intradermal injections of FANG Vaccine (1 × 107 or 2.5 × 107 Cells/ml injection). GMCSF, TGFβ1, TGFβ2, and furin proteins were quantified by enzyme-linked immunosorbent assay (ELISA). Safety and response were monitored. Vaccine manufacturing was successful in 42 of 46 patients of whom 27 received ≥1 Vaccine. There were no treatment-related serious adverse events. Most common grade 1, 2 adverse events included local induration (n = 14) and local erythema (n = 11) at injection site. Post-transfection mean product expression GMCSF increased from 7.3 to 1,108 pg/106 Cells/ml. Mean TGFβ1 and β2 effective target knockdown was 93.5 and 92.5% from baseline, respectively. Positive enzyme-linked immunospot (ELISPOT) response at month 4 was demonstrated in 9 of 18 patients serially assessed and correlated with survival duration from time of treatment (P = 0.025). Neither dose–adverse event nor dose–response relationship was noted. In conclusion, FANG Vaccine was safe and elicited an immune response correlating with prolonged survival. Phase II assessment is justified.
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phase ii study of belagenpumatucel l a transforming growth factor beta 2 antisense gene modified allogeneic Tumor Cell Vaccine in non small Cell lung cancer
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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phase ii study of belagenpumatucel l a transforming growth factor beta 2 antisense gene modified allogeneic Tumor Cell Vaccine in non small Cell lung cancer
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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Phase II Study of Belagenpumatucel-L, a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine in Non–Small-Cell Lung Cancer
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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Phase II study of a TGF-{beta}2 antisense gene modified allogeneic Tumor Cell Vaccine (Lucanix) in advanced NSCLC
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, D L Shawler, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Edward Devol, Terry Chamberlin, H FakhraiAbstract:7018 Background: Lucanix (L) is a non-viral gene based allogeneic Tumor Cell Vaccine which demonstrates enhancement of Tumor antigen recognition as a result of Transforming Growth Factor (TGF-β2) i...
John Nemunaitis - One of the best experts on this subject based on the ideXlab platform.
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phase ii study of belagenpumatucel l a transforming growth factor beta 2 antisense gene modified allogeneic Tumor Cell Vaccine in non small Cell lung cancer
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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phase ii study of belagenpumatucel l a transforming growth factor beta 2 antisense gene modified allogeneic Tumor Cell Vaccine in non small Cell lung cancer
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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Phase II Study of Belagenpumatucel-L, a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine in Non–Small-Cell Lung Cancer
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006Co-Authors: John Nemunaitis, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Casey Cunningham, Jodi Cutler, Padmasini Kumar, Beena O Pappen, Cody HamiltonAbstract:Purpose Belagenpumatucel-L is a nonviral gene-based allogeneic Tumor Cell Vaccine that demonstrates enhancement of Tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. Patients and Methods We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV non–small-Cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 × 107 Cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored. Results Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 × 107 Cells/injection (P = .0069). Focusing on the 61 late-stage (IIIB and IV) assessable patients, a 15% partial response rate was achieved. The estima...
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Phase II study of a TGF-{beta}2 antisense gene modified allogeneic Tumor Cell Vaccine (Lucanix) in advanced NSCLC
Journal of Clinical Oncology, 2006Co-Authors: John Nemunaitis, D L Shawler, Robert O. Dillman, Paul Schwarzenberger, Neil Senzer, Alex W. Tong, Edward Devol, Terry Chamberlin, H FakhraiAbstract:7018 Background: Lucanix (L) is a non-viral gene based allogeneic Tumor Cell Vaccine which demonstrates enhancement of Tumor antigen recognition as a result of Transforming Growth Factor (TGF-β2) i...
