Clinical trial NCT03262103 - References

Prostate Cancer — Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

Citation(s)

•   Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Fütterer JJ; European Society of Urogenital Radiology
  ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
•   Black PL, Hartmann D, Pennington R, Phillips H, Schneider M, Tribble HR, Talmadge JE
  Effect of tumor burden and route of administration on the immunotherapeutic properties of polyinosinic-polycytidylic acid stabilized with poly-L-lysine in carboxymethyl cellulose [Poly(I,C)-LC]. Int J Immunopharmacol. 1992 Nov;14(8):1341-53.
•   Bogunovic D, Manches O, Godefroy E, Yewdall A, Gallois A, Salazar AM, Marie I, Levy DE, Bhardwaj N
  TLR4 engagement during TLR3-induced proinflammatory signaling in dendritic cells promotes IL-10-mediated suppression of antitumor immunity. Cancer Res. 2011 Aug 15;71(16):5467-76. doi: 10.1158/0008-5472.CAN-10-3988. Epub 2011 Jul 5.
•   Bogunovic D, O'Neill DW, Belitskaya-Levy I, Vacic V, Yu YL, Adams S, Darvishian F, Berman R, Shapiro R, Pavlick AC, Lonardi S, Zavadil J, Osman I, Bhardwaj N
  Immune profile and mitotic index of metastatic melanoma lesions enhance clinical staging in predicting patient survival. Proc Natl Acad Sci U S A. 2009 Dec 1;106(48):20429-34. doi: 10.1073/pnas.0905139106. Epub 2009 Nov 13.
•   Brody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R
  In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9.
•   Butowski N, Chang SM, Junck L, DeAngelis LM, Abrey L, Fink K, Cloughesy T, Lamborn KR, Salazar AM, Prados MD
  A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: a North American Brain Tumor Consortium (NABTC01-05). J Neurooncol. 2009 Jan;91(2):175-82. doi: 10.1007/s11060-008-9693-3. Epub 2008 Sep 17.
•   Butowski N, Lamborn KR, Lee BL, Prados MD, Cloughesy T, DeAngelis LM, Abrey L, Fink K, Lieberman F, Mehta M, Ian Robins H, Junck L, Salazar AM, Chang SM
  A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas. J Neurooncol. 2009 Jan;91(2):183-9. doi: 10.1007/s11060-008-9705-3. Epub 2008 Oct 11.
•   Caskey M, Lefebvre F, Filali-Mouhim A, Cameron MJ, Goulet JP, Haddad EK, Breton G, Trumpfheller C, Pollak S, Shimeliovich I, Duque-Alarcon A, Pan L, Nelkenbaum A, Salazar AM, Schlesinger SJ, Steinman RM, Sékaly RP
  Synthetic double-stranded RNA induces innate immune responses similar to a live viral vaccine in humans. J Exp Med. 2011 Nov 21;208(12):2357-66. doi: 10.1084/jem.20111171. Epub 2011 Nov 7.
•   Chew V, Tow C, Huang C, Bard-Chapeau E, Copeland NG, Jenkins NA, Weber A, Lim KH, Toh HC, Heikenwalder M, Ng IO, Nardin A, Abastado JP
  Toll-like receptor 3 expressing tumor parenchyma and infiltrating natural killer cells in hepatocellular carcinoma patients. J Natl Cancer Inst. 2012 Dec 5;104(23):1796-807. doi: 10.1093/jnci/djs436. Epub 2012 Nov 29.
•   Davies ME, Field AK
  Effect of poly I:C/poly-L-lysine (poly ICL) on the development of murine osteogenic sarcoma. J Interferon Res. 1983;3(1):89-95.
•   Gnjatic S, Ritter E, Büchler MW, Giese NA, Brors B, Frei C, Murray A, Halama N, Zörnig I, Chen YT, Andrews C, Ritter G, Old LJ, Odunsi K, Jäger D
  Seromic profiling of ovarian and pancreatic cancer. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5088-93. doi: 10.1073/pnas.0914213107. Epub 2010 Mar 1.
•   Hartman LL, Crawford JR, Makale MT, Milburn M, Joshi S, Salazar AM, Hasenauer B, VandenBerg SR, MacDonald TJ, Durden DL
  Pediatric phase II trials of poly-ICLC in the management of newly diagnosed and recurrent brain tumors. J Pediatr Hematol Oncol. 2014 Aug;36(6):451-7. doi: 10.1097/MPH.0000000000000047.
•   Hawkins MJ, Levin M, Borden EC
  An Eastern Cooperative Oncology Group phase I-II pilot study of polyriboinosinic-polyribocytidylic acid poly-L-lysine complex in patients with metastatic malignant melanoma. J Biol Response Mod. 1985 Dec;4(6):664-8.
•   Houot R, Levy R
  T-cell modulation combined with intratumoral CpG cures lymphoma in a mouse model without the need for chemotherapy. Blood. 2009 Apr 9;113(15):3546-52. doi: 10.1182/blood-2008-07-170274. Epub 2008 Oct 21.
•   Kajiwara K, Morishima H, Akiyama K, Yanagihara Y
  Expression and function of the inducible costimulator ligand B7-H2 in human airway smooth muscle cells. Allergol Int. 2009 Dec;58(4):573-83. doi: 10.2332/allergolint.09-OA-0113. Epub 2009 Sep 25.
•   Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators
  Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.
•   Krown SE, Kerr D, Stewart WE 2nd, Field AK, Oettgen HF
  Phase I trials of poly(I,C) complexes in advanced cancer. J Biol Response Mod. 1985 Dec;4(6):640-9.
•   Levy HB, Levine AS
  Antitumor effects of interferon and poly ICLC, and their possible utility as anti-neoplastic agents in man. Tex Rep Biol Med. 1981-1982;41:653-62. Review.
•   Maluish AE, Reid JW, Crisp EA, Overton WR, Levy H, Foon KA, Herberman RB
  Immunomodulatory effects of poly(I,C)-LC in cancer patients. J Biol Response Mod. 1985 Dec;4(6):656-63.
•   Mangsbo SM, Ninalga C, Essand M, Loskog A, Tötterman TH
  CpG therapy is superior to BCG in an orthotopic bladder cancer model and generates CD4+ T-cell immunity. J Immunother. 2008 Jan;31(1):34-42.
•   Mitsuhashi M
  Ex vivo simulation of leukocyte function: stimulation of specific subset of leukocytes in whole blood followed by the measurement of function-associated mRNAs. J Immunol Methods. 2010 Dec 15;363(1):95-100. doi: 10.1016/j.jim.2010.10.002. Epub 2010 Oct 15.
•   Morgan ET, Norman CA
  Pretranslational suppression of cytochrome P-450h (IIC11) gene expression in rat liver after administration of interferon inducers. Drug Metab Dispos. 1990 Sep-Oct;18(5):649-53.
•   Morse MA, Chapman R, Powderly J, Blackwell K, Keler T, Green J, Riggs R, He LZ, Ramakrishna V, Vitale L, Zhao B, Butler SA, Hobeika A, Osada T, Davis T, Clay T, Lyerly HK
  Phase I study utilizing a novel antigen-presenting cell-targeted vaccine with Toll-like receptor stimulation to induce immunity to self-antigens in cancer patients. Clin Cancer Res. 2011 Jul 15;17(14):4844-53. doi: 10.1158/1078-0432.CCR-11-0891. Epub 2011 Jun 1.
•   Nair SS…
  Salazar A, Galsky M, Bhardwaj N and Tewari A. Phase I study of in situ autologous vaccination for prostate cancer in a neo-adjuvant setting [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT096
•   Newell EW, Sigal N, Bendall SC, Nolan GP, Davis MM
  Cytometry by time-of-flight shows combinatorial cytokine expression and virus-specific cell niches within a continuum of CD8+ T cell phenotypes. Immunity. 2012 Jan 27;36(1):142-52. doi: 10.1016/j.immuni.2012.01.002. Erratum in: Immunity. 2013 Jan 24;38(1):198-9.
•   North RJ, Dunn PL, Havell EA
  A role for tumor necrosis factor in poly(I:C)-induced hemorrhagic necrosis and T-cell-dependent regression of a murine sarcoma. J Interferon Res. 1991 Dec;11(6):333-40.
•   Okada H, Kalinski P, Ueda R, Hoji A, Kohanbash G, Donegan TE, Mintz AH, Engh JA, Bartlett DL, Brown CK, Zeh H, Holtzman MP, Reinhart TA, Whiteside TL, Butterfield LH, Hamilton RL, Potter DM, Pollack IF, Salazar AM, Lieberman FS
  Induction of CD8+ T-cell responses against novel glioma-associated antigen peptides and clinical activity by vaccinations with {alpha}-type 1 polarized dendritic cells and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in patients with recurrent malignant glioma. J Clin Oncol. 2011 Jan 20;29(3):330-6. doi: 10.1200/JCO.2010.30.7744. Epub 2010 Dec 13.
•   Pilaro AM, Taub DD, McCormick KL, Williams HM, Sayers TJ, Fogler WE, Wiltrout RH
  TNF-alpha is a principal cytokine involved in the recruitment of NK cells to liver parenchyma. J Immunol. 1994 Jul 1;153(1):333-42.
•   Pound CR, Partin AW, Eisenberger MA, Chan DW, Pearson JD, Walsh PC
  Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999 May 5;281(17):1591-7.
•   Rosenfeld MR, Chamberlain MC, Grossman SA, Peereboom DM, Lesser GJ, Batchelor TT, Desideri S, Salazar AM, Ye X
  A multi-institution phase II study of poly-ICLC and radiotherapy with concurrent and adjuvant temozolomide in adults with newly diagnosed glioblastoma. Neuro Oncol. 2010 Oct;12(10):1071-7. doi: 10.1093/neuonc/noq071. Epub 2010 Jul 8.
•   Rosenkrantz AB, Lim RP, Haghighi M, Somberg MB, Babb JS, Taneja SS
  Comparison of interreader reproducibility of the prostate imaging reporting and data system and likert scales for evaluation of multiparametric prostate MRI. AJR Am J Roentgenol. 2013 Oct;201(4):W612-8. doi: 10.2214/AJR.12.10173.
•   Röthke M, Blondin D, Schlemmer HP, Franiel T
  [PI-RADS classification: structured reporting for MRI of the prostate]. Rofo. 2013 Mar;185(3):253-61. doi: 10.1055/s-0032-1330270. Epub 2013 Feb 12. German.
•   Sabbatini P, Tsuji T, Ferran L, Ritter E, Sedrak C, Tuballes K, Jungbluth AA, Ritter G, Aghajanian C, Bell-McGuinn K, Hensley ML, Konner J, Tew W, Spriggs DR, Hoffman EW, Venhaus R, Pan L, Salazar AM, Diefenbach CM, Old LJ, Gnjatic S
  Phase I trial of overlapping long peptides from a tumor self-antigen and poly-ICLC shows rapid induction of integrated immune response in ovarian cancer patients. Clin Cancer Res. 2012 Dec 1;18(23):6497-508. doi: 10.1158/1078-0432.CCR-12-2189. Epub 2012 Oct 2.
•   Salazar AM, Erlich RB, Mark A, Bhardwaj N, Herberman RB
  Therapeutic in situ autovaccination against solid cancers with intratumoral poly-ICLC: case report, hypothesis, and clinical trial. Cancer Immunol Res. 2014 Aug;2(8):720-4. doi: 10.1158/2326-6066.CIR-14-0024. Epub 2014 May 6.
•   Salazar AM, Levy HB, Ondra S, Kende M, Scherokman B, Brown D, Mena H, Martin N, Schwab K, Donovan D, Dougherty D, Pulliam M, Ippolito M, Graves M, Brown H, Ommaya A
  Long-term treatment of malignant gliomas with intramuscularly administered polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose: an open pilot study. Neurosurgery. 1996 Jun;38(6):1096-103; discussion 1103-4.
•   Siegel R, Ma J, Zou Z, Jemal A
  Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7. Erratum in: CA Cancer J Clin. 2014 Sep-Oct;64(5):364.
•   Sivori S, Falco M, Della Chiesa M, Carlomagno S, Vitale M, Moretta L, Moretta A
  CpG and double-stranded RNA trigger human NK cells by Toll-like receptors: induction of cytokine release and cytotoxicity against tumors and dendritic cells. Proc Natl Acad Sci U S A. 2004 Jul 6;101(27):10116-21. Epub 2004 Jun 24.
•   Sonpavde G, Di Lorenzo G, Higano CS, Kantoff PW, Madan R, Shore ND
  The role of sipuleucel-T in therapy for castration-resistant prostate cancer: a critical analysis of the literature. Eur Urol. 2012 Apr;61(4):639-47. doi: 10.1016/j.eururo.2011.10.027. Epub 2011 Oct 24. Review.
•   Stevenson HC, Abrams PG, Schoenberger CS, Smalley RB, Herberman RB, Foon KA
  A phase I evaluation of poly(I,C)-LC in cancer patients. J Biol Response Mod. 1985 Dec;4(6):650-5.
•   Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS
  Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.
•   Zhu X, Fallert-Junecko BA, Fujita M, Ueda R, Kohanbash G, Kastenhuber ER, McDonald HA, Liu Y, Kalinski P, Reinhart TA, Salazar AM, Okada H
  Poly-ICLC promotes the infiltration of effector T cells into intracranial gliomas via induction of CXCL10 in IFN-alpha and IFN-gamma dependent manners. Cancer Immunol Immunother. 2010 Sep;59(9):1401-9. doi: 10.1007/s00262-010-0876-3. Epub 2010 Jun 12.

Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy

Details for clinical trial NCT03262103