The Experts below are selected from a list of 183 Experts worldwide ranked by ideXlab platform
Sacha Gnjatic - One of the best experts on this subject based on the ideXlab platform.
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poly iclc as an adjuvant for ny eso 1 protein vaccination with or without Montanide ISA 51 vg in patients with melanoma
Journal of Clinical Oncology, 2015Co-Authors: Rachel Lubong Sabado, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Sacha Gnjatic, Anna C Pavlick, Meredith Spadaccia, Bike Su Oner, Hanqing Dong, Caroline MurenAbstract:e14034 Background: Poly-ICLC (Hiltonol, Oncovir Inc) is a synthetic dsRNA complex which directly activates DCs and also triggers NK cells to kill tumor cells. Compared to LPS and R848, Poly-ICLC is...
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phase i ii study of the tlr3 agonist poly iclc as an adjuvant for ny eso 1 protein vaccination with or without Montanide ISA 51 vg in patients with melanoma
Journal of Clinical Oncology, 2014Co-Authors: Rachel Lubong Sabado, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Sacha Gnjatic, Anna C Pavlick, Meredith Spadaccia, Caroline Muren, Patrick A Ott, Crystal EscanoAbstract:TPS9119 Background: Poly-ICLC is a synthetic dsRNA complex which directly activates DCs and also triggers NK cells to kill tumor cells. Compared to LPS and R848, Poly-ICLC is the most potent TLR adjuvant due to its induction of cytokines such as IL-12 in the absence of IL-10, and maintenance of high levels of CD80 and CD86 in DCs. This study assessed the therapeutic potential of TLR3 activation by adding Poly-ICLC to a NY-ESO-1 protein vaccine with and without Montanide in surgically resected stage IIB-IV melanoma patients. Methods: In Phase I of the study, patients received subcutaneous injection of 100μg NY-ESO-1 protein and 1.1mL Montanide emulsified in escalating doses of Poly-ICLC: 0.35mg (cohort 1; N=3), 0.70mg (cohort 2; N=3), or 1.4mg (cohort 3; N=3). The cycles of vaccination were repeated every 3 weeks for a total of 4 cycles. In Phase II of the study, patients were randomized to subcutaneous vaccination of 100μg NY-ESO-1 protein with 1.4 mg Poly-ICLC, the dose established in the Phase I of the ...
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phase i ii study of the tlr3 agonist poly iclc as an adjuvant for ny eso 1 protein vaccination with or without Montanide ISA 51 vg in patients with melanoma
Journal of Clinical Oncology, 2014Co-Authors: Rachel Lubong Sabado, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Sacha Gnjatic, Anna C Pavlick, Meredith Spadaccia, Caroline Muren, Patrick A Ott, Crystal EscanoAbstract:TPS9119 Background: Poly-ICLC is a synthetic dsRNA complex which directly activates DCs and also triggers NK cells to kill tumor cells. Compared to LPS and R848, Poly-ICLC is the most potent TLR ad...
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phase i ii study of resiquimod as an immunologic adjuvant for ny eso 1 protein vaccination in patients with melanoma
Journal of Clinical Oncology, 2012Co-Authors: Rachel Lubong Sabado, Crystal M Cruz, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Farbod Darvishian, Luis Chiriboga, Sacha Gnjatic, Anna C Pavlick, J EscalonAbstract:2589 Background: The TLR 7/8 agonist, Resiquimod has been shown to induce local activation of immune cells, production of cytokines, and antigen-presentation by dendritic cells, features desirable for cancer vaccine adjuvants. In this study, we evaluated the safety and immunogenicity of vaccination with NY-ESO-1 protein emulsified in Montanide ISA-51 VG when given with or without Resiquimod in patients with surgically resected stage IIB-IV melanoma patients. Methods: This is a two-part study design. Part I represents an open-label dose-escalation with Resiquimod using 2 cohorts treated with 100ug NY-ESO-1 protein emulsified in 1.25mL Montanide (day1) followed by topical application of 1000mg of the 0.2% Resiquimod gel on days 1 and 3 for cohort-1 (N=3) or days 1, 3, and 5 for cohort-2 (N=3). The cycles were repeated every 3 weeks, total of 4 cycles. Part II of the study is blinded. Patients were randomized to receive 100ug NY-ESO-1 protein emulsified in 1.25mL Montanide (day1) followed by topical applicat...
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Tumor-reactive CD8+ T-cell responses after vaccination with NY-ESO-1 peptide, CpG 7909 and Montanide ISA-51: association with survival.
International journal of cancer, 2010Co-Authors: Julia Karbach, Sacha Gnjatic, Armin Bender, Antje Neumann, Eckhart Weidmann, Jianda Yuan, Cathy A. Ferrara, Eric Hoffmann, Lloyd J. Old, Nasser K. AltorkiAbstract:Peptide-based vaccines have led to the induction of antigen-specific CD8(+) T-cell responses in patients with NY-ESO-1 positive cancers. However, vaccine-induced T-cell responses did not generally correlate with improved survival. Therefore, we tested whether a synthetic CpG 7909 ODN (deoxycytidyl-deoxyguanosin oligodeoxy-nucleotides) mixed with NY-ESO-1 peptide p157-165 and incomplete Freund's adjuvants (Montanide(R) ISA-51) led to enhanced NY-ESO-1 antigen-specific CD8(+) immune responses in patients with NY-ESO-1 or LAGE-1 expressing tumors. Of 14 HLA-A2+ patients enrolled in the study, 5 patients withdrew prematurely because of progressive disease and 9 patients completed 1 cycle of immunization. Nine of 14 patients developed measurable and sustained antigen-specific CD8(+) T-cell responses: Four had detectable CD8+ T-cells against NY-ESO-1 after only 2 vaccinations, whereas 5 patients showed a late-onset but durable induction of NY-ESO-1 p157-165 specific T-cell response during continued vaccination after 4 months. In 6 patients, vaccine-induced antigen-specific T-cells became detectable ex vivo and reached frequencies of up to 0.16 % of all circulating CD8(+) T-cells. Postvaccine T-cell clones were shown to recognize and lyse NY-ESO-1 expressing tumor cell lines in vitro. In 6 of 9 patients developing NY-ESO-1-specific immune responses, a favorable clinical outcome with overall survival times of 43+, 42+, 42+, 39+, 36+ and 27+ months, respectively, was observed.
Ronald Scotland - One of the best experts on this subject based on the ideXlab platform.
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alum with interleukin 12 augments immunity to a melanoma peptide vaccine correlation with time to relapse in patients with resected high risk disease
Clinical Cancer Research, 2007Co-Authors: Omid Hamid, Ronald Scotland, Susan Groshen, Shirley Sian, Jolie Solomon, Marile Garcia, J. S. WeberAbstract:Purpose: We attempted to augment immunity to melanoma antigens using interleukin-12 (IL-12) with aluminum hydroxide (alum) for sustained release or granulocyte macrophage colony-stimulating factor (GM-CSF) added to a multipeptide vaccine. Experimental Design: Sixty patients with high-risk resected melanoma were randomized to receive melanoma peptides gp100 209-217 (210M), MART-1 26-35 (27L), and tyrosinase 368-376 (370D) with adjuvant Montanide ISA 51 and either IL-12 at 30 ng/kg with alum (group A), IL-12 at 100 ng/kg with alum (group B), or IL-12 at 30 ng/kg with 250 μg GM-CSF (group C). Results: Three patients had stage IIC (5%), 50 had stage III (83%), and 7 had stage IV (12%) melanoma. Most toxicities were grade 1/2 and resolved rapidly. Significant toxicity included grade 3 colitis and visual changes and grade 3 headache resolving after stopping IL-12 but continuing peptide vaccine. A higher rate of post-vaccine 6-month immune response to gp100 and MART-1 was observed in group A (15 of 19) or B (19 of 20) that received IL-12 plus alum versus group C with IL-12/GM-CSF (4 of 21; P P = 0.031 for gp100 and P = 0.010 for MART-1); both were higher than group C ( P P P = 0.012). Conclusions: IL-12 with alum augmented an immune response to melanoma antigens compared with IL-12 with GM-CSF. Immune response was associated with time to relapse.
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phase ii trial of extended dose anti ctla 4 antibody ipilimumab formerly mdx 010 with a multi peptide vaccine for resected stages iiic and iv melanoma
Journal of Clinical Oncology, 2006Co-Authors: J. S. Weber, Ronald Scotland, Jolie Snively, Michael Yellin, S Targan, M Garcia, Steven Fischkoff, G NicholAbstract:9023 Background: Ipilimumab is a human anti-CTLA-4 antibody shown to have clinical activity in melanoma that is associated with immune-related adverse events (IrAEs). Methods: 50 HLA A*0201 positive patients with resected stages IIIC/IV melanoma received MART-1/gp100/tyrosinase peptides with adjuvant Montanide ISA 51 12 times subcutaneously with Ipilimumab at 3 or 10 mg/kg intravenously every 8 weeks for 12 months, and 25 HLA A *0201 negative patients received Ipilimumab alone at 10 mg/kg. Primary endpoints were toxicity and the achievement of a 40% rate of tolerable IrAEs. Immune responses measured by ELISPOT and tetramer assays, and time to relapse were also assessed. 3 melanoma peptides were administered at 1000 mcg/dose each. Results: Median age was 58, with 44 men and 31 women. 46 patients had stage IV, and 29 had stage IIIC resected disease. 19/75 (25%) patients had grades 3–4 IrAEs that were dose-limiting. No patient with dose limiting toxicity required hospitalization and all returned to baseline ...
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randomized phase ii trial of melanoma peptides with Montanide ISA 51 and different doses of il 12 with alum for resected stages iic iii and iv melanoma
Journal of Clinical Oncology, 2005Co-Authors: Jeffrey S. Weber, Susan Groshen, Jolie Snively, Shirley Sian, Joan C Delto, Conway Gee, Ronald ScotlandAbstract:2506 Background: Based on a prior study (Lee et al, J Clin Oncol 19: 3836 2001), we attempted to augment immune responses to defined melanoma antigens with IL-12 and/or GM-CSF added to a multi-pept...
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autoimmunity in a phase i trial of a fully human anti cytotoxic t lymphocyte antigen 4 monoclonal antibody with multiple melanoma peptides and Montanide ISA 51 for patients with resected stages iii and iv melanoma
Journal of Clinical Oncology, 2005Co-Authors: Kristin M Sanderson, Ronald Scotland, Susan Groshen, Jolie Snively, Shirley Sian, G Nichol, Thomas P Davis, Tibor Keler, Michael Yellin, Jeffrey S. WeberAbstract:Purpose Nineteen patients with high-risk resected stage III and IV melanoma were immunized with three tumor antigen epitope peptides from gp100, MART-1, and tyrosinase emulsified with adjuvant Montanide ISA 51 and received a fully human anti-cytotoxic T-lymphocyte antigen-4 (anti–CTLA-4) monoclonal antibody MDX-010. Each of three cohorts received escalating doses of antibody with vaccine primarily to evaluate the toxicities and maximum-tolerated dose (MTD) of MDX-010 with vaccine. MDX-010 pharmacokinetics and immune responses were secondary end points. Patients and Methods Peptide immunizations with MDX-010 were administered every 4 weeks for 6 months and then every 12 weeks for 6 months. A leukapheresis to obtain peripheral-blood mononuclear cells for immune analyses was performed before treatment and after the sixth vaccination. Patients were observed until relapse. Results Grade 3 gastrointestinal (GI) toxicity (diarrhea or abdominal pain) was observed in three patients in the highest dose cohort and o...
Galina V Yamshchikov - One of the best experts on this subject based on the ideXlab platform.
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mage a1 mage a10 and gp100 derived peptides are immunogenic when combined with granulocyte macrophage colony stimulating factor and Montanide ISA 51 adjuvant and administered as part of a multipeptide vaccine for melanoma
Journal of Immunology, 2005Co-Authors: Kimberly A Chianesebullock, Gina R. Petroni, Patrice Y. Neese, Galina V Yamshchikov, Sarah Hibbitts, Jennifer Pressley, Courtney F Garbee, Cheryl F Murphy, Eric A Bissonette, William W. GroshAbstract:Twelve peptides derived from melanocyte differentiation proteins and cancer-testis Ags were combined and administered in a single mixture to patients with resected stage IIB, III, or IV melanoma. Five of the 12 peptides included in this mixture had not previously been evaluated for their immunogenicity in vivo following vaccination. We report in this study that at least three of these five peptides (MAGE-A1(96-104), MAGE-A10(254-262), and gp100(614-622)) are immunogenic when administered with GM-CSF in Montanide ISA-51 adjuvant. T cells secreting IFN-gamma in response to peptide-pulsed target cells were detected in peripheral blood and in the sentinel immunized node, the node draining a vaccine site, after three weekly injections. The magnitude of response typically reached a maximum after two vaccines, and though sometimes diminished thereafter, those responses typically were still detectable 6 wks after the last vaccines. Most importantly, tumor cell lines expressing the appropriate HLA-A restriction element and MAGE-A1, MAGE-A10, or gp100 proteins were lysed by corresponding CTL. This report supports the continued use of the MAGE-A1(96-104), MAGE-A10(254-262), and gp100(614-622) epitopes in peptide-based melanoma vaccines and thus expands the list of immunogenic peptide Ags available for human use. Cancer-testis Ags are expressed in multiple types of cancer; thus the MAGE-A1(96-104) and MAGE-A10(254-262) peptides may be considered for inclusion in vaccines against cancers of other histologic types, in addition to melanoma.
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clinical and immunologic results of a randomized phase ii trial of vaccination using four melanoma peptides either administered in granulocyte macrophage colony stimulating factor in adjuvant or pulsed on dendritic cells
Journal of Clinical Oncology, 2003Co-Authors: Craig L. Slingluff, Gina R. Petroni, Donna H. Deacon, Galina V Yamshchikov, Holly Galavotti, Shannon Eastham, Sarah Hibbitts, Donna L Barnd, James W Patterson, David TeatesAbstract:Purpose: To determine clinical and immunologic responses to a multipeptide melanoma vaccine regimen, a randomized phase II trial was performed. Patients and Methods: Twenty-six patients with advanced melanoma were randomly assigned to vaccination with a mixture of four gp100 and tyrosinase peptides restricted by HLA-A1, HLA-A2, and HLA-A3, plus a tetanus helper peptide, either in an emulsion with granulocyte-macrophage colony-stimulating factor (GM-CSF) and Montanide ISA-51 adjuvant (Seppic Inc, Fairfield, NJ), or pulsed on monocyte-derived dendritic cells (DCs). Systemic low-dose interleukin-2 (Chiron, Emeryville, CA) was given to both groups. T-lymphocyte responses were assessed, by interferon gamma ELIspot assay (Chiron, Emeryville, CA), in peripheral-blood lymphocytes (PBLs) and in a lymph node draining a vaccine site (sentinel immunized node [SIN]). Results: In patients vaccinated with GM-CSF in adjuvant, T-cell responses to melanoma peptides were observed in 42% of PBLs and 80% of SINs, but in patie...
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phase i trial of a melanoma vaccine with gp100280 288 peptide and tetanus helper peptide in adjuvant immunologic and clinical outcomes
Clinical Cancer Research, 2001Co-Authors: Craig L. Slingluff, Patrice Y. Neese, Donna H. Deacon, Galina V Yamshchikov, Holly Galavotti, Shannon Eastham, Victor H Engelhard, Dave Kittlesen, Sarah Hibbitts, William W. GroshAbstract:A melanoma vaccine composed of HLA-A2-restricted peptide YLEPGPVTA (gp100 280 ), with or without a modified T-helper epitope from tetanus toxoid AQYIKANSKFIGITEL, has been evaluated in a Phase I trial to assess safety and immunological response. The vaccines were administered s.c. in either of two adjuvants, Montanide ISA-51 or QS-21, to 22 patients with high-risk resected melanoma (stage IIB–IV). Local and systemic toxicities were mild and transient. We detected CTL responses to the gp100 280 peptide in peripheral blood in 14% of patients. Helper T-cell responses to the tetanus helper peptide were detected in 79% of patients and had a Th1 cytokine profile. One patient with a CTL response to gp100 had a recurrence in a lymph node 2 years later; her nodes contained CD8 + cells reactive to gp100 280 (0.24%), which proliferated in response to peptide. The overall survival of patients is 75% (95% confidence interval, 57–94%) at 4.7 years follow-up, which compares favorably with expected survival. Four of 14 patients who completed at least six vaccines subsequently developed metastases, all of which were solitary and surgically resectable. They remain alive and clinically free of disease at last follow-up. Data from this trial demonstrate immunogenicity of the gp100 280 peptide and suggest that immune responses may persist long-term in some patients. The frequency and magnitude of the CTL response may be improved with more aggressive vaccination regimens. Although this Phase I study was not intended to evaluate clinical benefit, the excellent survival of patients on this protocol suggests the possibility of a benefit that should be assessed in future studies.
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evaluation of peptide vaccine immunogenicity in draining lymph nodes and peripheral blood of melanoma patients
International Journal of Cancer, 2001Co-Authors: Galina V Yamshchikov, William W. Grosh, Patrice Y. Neese, Donna H. Deacon, Holly Galavotti, Shannon Eastham, Donna L Barnd, James W Patterson, David Teates, Gina R. PetroniAbstract:Many peptide epitopes for cytotoxic T lymphocytes (CTLs) have been identified from melanocytic differentiation proteins. Vaccine trials with these peptides have been limited mostly to those associated with HLA-A2, and immune responses have been detected inconsistently. Cases of clinical regression have been observed after peptide vaccination in some trials, but melanoma regressions have not correlated well with T-cell responses measured in peripheral blood lymphocytes (PBLs). We vaccinated stage IV melanoma patients with a mixture of gp100 and tyrosinase peptides restricted by HLA-A1 (DAEKSDICTDEY), HLA-A2 (YLEPGPVTA and YMDGTMSQV) and HLA-A3 (ALLAVGATK) in an emulsion with GM-CSF and Montanide ISA-51 adjuvant. CTL responses were assessed in PBLs and in a lymph node draining a vaccine site (sentinel immunized node, SIN). We found CTL responses to vaccinating peptides in the SIN in 5/5 patients (100%). Equivalent assays detected peptide-reactive CTLs in PBLs of 2 of these 5 patients (40%). CTLs expanded from the SIN lysed melanoma cells naturally expressing tyrosinase or gp100. We demonstrated immunogenicity for peptides restricted by HLA-A1 and -A3 and for 1 HLA-A2 restricted peptide, YMDGTMSQV. Immune monitoring of clinical trials by evaluation of PBLs alone may under-estimate immunogenicity; evaluation of SIN provides a new and sensitive approach for defining responses to tumor vaccines and correlating these responses with clinical outcomes. This combination of an immunogenic vaccine strategy with a sensitive analysis of CTL responses demonstrates the potential for inducing and detecting anti-tumor immune responses in the majority of melanoma patients. © 2001 Wiley-Liss, Inc.
David Teates - One of the best experts on this subject based on the ideXlab platform.
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clinical and immunologic results of a randomized phase ii trial of vaccination using four melanoma peptides either administered in granulocyte macrophage colony stimulating factor in adjuvant or pulsed on dendritic cells
Journal of Clinical Oncology, 2003Co-Authors: Craig L. Slingluff, Gina R. Petroni, Donna H. Deacon, Galina V Yamshchikov, Holly Galavotti, Shannon Eastham, Sarah Hibbitts, Donna L Barnd, James W Patterson, David TeatesAbstract:Purpose: To determine clinical and immunologic responses to a multipeptide melanoma vaccine regimen, a randomized phase II trial was performed. Patients and Methods: Twenty-six patients with advanced melanoma were randomly assigned to vaccination with a mixture of four gp100 and tyrosinase peptides restricted by HLA-A1, HLA-A2, and HLA-A3, plus a tetanus helper peptide, either in an emulsion with granulocyte-macrophage colony-stimulating factor (GM-CSF) and Montanide ISA-51 adjuvant (Seppic Inc, Fairfield, NJ), or pulsed on monocyte-derived dendritic cells (DCs). Systemic low-dose interleukin-2 (Chiron, Emeryville, CA) was given to both groups. T-lymphocyte responses were assessed, by interferon gamma ELIspot assay (Chiron, Emeryville, CA), in peripheral-blood lymphocytes (PBLs) and in a lymph node draining a vaccine site (sentinel immunized node [SIN]). Results: In patients vaccinated with GM-CSF in adjuvant, T-cell responses to melanoma peptides were observed in 42% of PBLs and 80% of SINs, but in patie...
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evaluation of peptide vaccine immunogenicity in draining lymph nodes and peripheral blood of melanoma patients
International Journal of Cancer, 2001Co-Authors: Galina V Yamshchikov, William W. Grosh, Patrice Y. Neese, Donna H. Deacon, Holly Galavotti, Shannon Eastham, Donna L Barnd, James W Patterson, David Teates, Gina R. PetroniAbstract:Many peptide epitopes for cytotoxic T lymphocytes (CTLs) have been identified from melanocytic differentiation proteins. Vaccine trials with these peptides have been limited mostly to those associated with HLA-A2, and immune responses have been detected inconsistently. Cases of clinical regression have been observed after peptide vaccination in some trials, but melanoma regressions have not correlated well with T-cell responses measured in peripheral blood lymphocytes (PBLs). We vaccinated stage IV melanoma patients with a mixture of gp100 and tyrosinase peptides restricted by HLA-A1 (DAEKSDICTDEY), HLA-A2 (YLEPGPVTA and YMDGTMSQV) and HLA-A3 (ALLAVGATK) in an emulsion with GM-CSF and Montanide ISA-51 adjuvant. CTL responses were assessed in PBLs and in a lymph node draining a vaccine site (sentinel immunized node, SIN). We found CTL responses to vaccinating peptides in the SIN in 5/5 patients (100%). Equivalent assays detected peptide-reactive CTLs in PBLs of 2 of these 5 patients (40%). CTLs expanded from the SIN lysed melanoma cells naturally expressing tyrosinase or gp100. We demonstrated immunogenicity for peptides restricted by HLA-A1 and -A3 and for 1 HLA-A2 restricted peptide, YMDGTMSQV. Immune monitoring of clinical trials by evaluation of PBLs alone may under-estimate immunogenicity; evaluation of SIN provides a new and sensitive approach for defining responses to tumor vaccines and correlating these responses with clinical outcomes. This combination of an immunogenic vaccine strategy with a sensitive analysis of CTL responses demonstrates the potential for inducing and detecting anti-tumor immune responses in the majority of melanoma patients. © 2001 Wiley-Liss, Inc.
Rachel Lubong Sabado - One of the best experts on this subject based on the ideXlab platform.
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poly iclc as an adjuvant for ny eso 1 protein vaccination with or without Montanide ISA 51 vg in patients with melanoma
Journal of Clinical Oncology, 2015Co-Authors: Rachel Lubong Sabado, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Sacha Gnjatic, Anna C Pavlick, Meredith Spadaccia, Bike Su Oner, Hanqing Dong, Caroline MurenAbstract:e14034 Background: Poly-ICLC (Hiltonol, Oncovir Inc) is a synthetic dsRNA complex which directly activates DCs and also triggers NK cells to kill tumor cells. Compared to LPS and R848, Poly-ICLC is...
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phase i ii study of the tlr3 agonist poly iclc as an adjuvant for ny eso 1 protein vaccination with or without Montanide ISA 51 vg in patients with melanoma
Journal of Clinical Oncology, 2014Co-Authors: Rachel Lubong Sabado, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Sacha Gnjatic, Anna C Pavlick, Meredith Spadaccia, Caroline Muren, Patrick A Ott, Crystal EscanoAbstract:TPS9119 Background: Poly-ICLC is a synthetic dsRNA complex which directly activates DCs and also triggers NK cells to kill tumor cells. Compared to LPS and R848, Poly-ICLC is the most potent TLR adjuvant due to its induction of cytokines such as IL-12 in the absence of IL-10, and maintenance of high levels of CD80 and CD86 in DCs. This study assessed the therapeutic potential of TLR3 activation by adding Poly-ICLC to a NY-ESO-1 protein vaccine with and without Montanide in surgically resected stage IIB-IV melanoma patients. Methods: In Phase I of the study, patients received subcutaneous injection of 100μg NY-ESO-1 protein and 1.1mL Montanide emulsified in escalating doses of Poly-ICLC: 0.35mg (cohort 1; N=3), 0.70mg (cohort 2; N=3), or 1.4mg (cohort 3; N=3). The cycles of vaccination were repeated every 3 weeks for a total of 4 cycles. In Phase II of the study, patients were randomized to subcutaneous vaccination of 100μg NY-ESO-1 protein with 1.4 mg Poly-ICLC, the dose established in the Phase I of the ...
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phase i ii study of the tlr3 agonist poly iclc as an adjuvant for ny eso 1 protein vaccination with or without Montanide ISA 51 vg in patients with melanoma
Journal of Clinical Oncology, 2014Co-Authors: Rachel Lubong Sabado, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Sacha Gnjatic, Anna C Pavlick, Meredith Spadaccia, Caroline Muren, Patrick A Ott, Crystal EscanoAbstract:TPS9119 Background: Poly-ICLC is a synthetic dsRNA complex which directly activates DCs and also triggers NK cells to kill tumor cells. Compared to LPS and R848, Poly-ICLC is the most potent TLR ad...
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phase i ii study of resiquimod as an immunologic adjuvant for ny eso 1 protein vaccination in patients with melanoma
Journal of Clinical Oncology, 2012Co-Authors: Rachel Lubong Sabado, Crystal M Cruz, Isabelita Vengco, Farah Hasan, Rose Marie Holman, Farbod Darvishian, Luis Chiriboga, Sacha Gnjatic, Anna C Pavlick, J EscalonAbstract:2589 Background: The TLR 7/8 agonist, Resiquimod has been shown to induce local activation of immune cells, production of cytokines, and antigen-presentation by dendritic cells, features desirable for cancer vaccine adjuvants. In this study, we evaluated the safety and immunogenicity of vaccination with NY-ESO-1 protein emulsified in Montanide ISA-51 VG when given with or without Resiquimod in patients with surgically resected stage IIB-IV melanoma patients. Methods: This is a two-part study design. Part I represents an open-label dose-escalation with Resiquimod using 2 cohorts treated with 100ug NY-ESO-1 protein emulsified in 1.25mL Montanide (day1) followed by topical application of 1000mg of the 0.2% Resiquimod gel on days 1 and 3 for cohort-1 (N=3) or days 1, 3, and 5 for cohort-2 (N=3). The cycles were repeated every 3 weeks, total of 4 cycles. Part II of the study is blinded. Patients were randomized to receive 100ug NY-ESO-1 protein emulsified in 1.25mL Montanide (day1) followed by topical applicat...