Download File - JOHN J. HADDAD, Ph.D.

More documents

Recommendations

Info

Personalized Cancer Vaccines 81 early and informed decision-making through prospectively defined ‘go’ or ‘no go’ decision points, use of biologic end points, adjusted clinical end points, early use of randomized trials, and adaptive design components, where applicable.” However, there remain challenges with being able to effectively apply some of these concepts in the better-prognosis patient setting. The ability to glean reliable information regarding potential efficacy at time points early in a clinical trial remains a challenge and a barrier to accelerated decision making. Continued innovation and dialogue in the regulatory process for cancer vaccine development will be critical for the sustained investment of time, effort, and funds—without which progress in this novel and important area may never be achieved. REFERENCES 1. Heifets L. Centennial of Metchnikoff’s discovery. J Reticuloendothel Soc 1982; 31(5): 381–391. 2. Siegel JH, Janis R, Alper JC, et al. Disseminated visceral Kaposi’s sarcoma. Appearance after human renal homograft operation. JAMA 1969; 207(8):1493–1496. 3. Myers BD, Kessler E, Levi J, et al. Kaposi’s sarcoma in kidney transplant recipients. Arch Intern Med 1974; 133(2):307–311. 4. Penn I. Kaposi’s sarcoma in organ transplant recipients: report of 20 cases. Transplantation 1979; 27(1):8–11. 5. Euvrard S, Kanitakis J, Claudy A. Skin cancers after organ transplantation. N Engl J Med 2003; 348(17):1681–1691. 6. Klein G, Sjorgen HO, Klein E, et al. Demonstration of resistance against methylcholanthrene-induced sarcomas in the primary autochthonous host. Cancer Res 1960; 20: 1561–1562. 7. Klein G. Tumor antigens. Annu Rev Microbiol 1966; 20:223–252. 8. Burnet FM. Immunological aspects of malignant disease. Lancet 1967; 1(7501): 1171–1174. 9. Burnet FM. Immunological surveillance in neoplasia. Transplant Rev 1971; 7:3–25. 10. Dunn GP, Old LJ, Schreiber RD. The immunobiology of cancer immunosurveillance and immunoediting. Immunity 2004; 21(2):137–148. 11. Stebbing J, Bower M. What can oncologists learn from HIV? Lancet Oncol 2003; 4(7): 438–445. 12. Boshoff C, Weiss R. AIDS-related malignancies. Nat Rev Cancer 2002; 2(5):373–382. 13. Portsmouth S, Stebbing J, Gill J, et al. A comparison of regimens based on nonnucleoside reverse transcriptase inhibitors or protease inhibitors in preventing Kaposi’s sarcoma. AIDS 2003; 17(11):F17–F22. 14. Powles T, Thirlwell C, Nelson M, et al. Immune reconstitution inflammatory syndrome mimicking relapse of AIDS related lymphoma in patients with HIV 1 infection. Leuk Lymphoma 2003; 44(8):1417–1419. 15. Bower M, Nelson M, Young AM, et al. Immune reconstitution inflammatory syndrome associated with Kaposi’s sarcoma. J Clin Oncol 2005; 23(22):5224–5228. 16. Goldman B. Cancer vaccines: finding the best way to train the immune system. J Natl Cancer Inst 2002; 94(20):1523–1526.
82 Teofilovici and Wentworth 17. Basic concepts of immunology and neuroimmunology. Available at: http://www. medscape.com. Accessed 9/19/2007. 18. Choudhury A, Mosolits S, Kokhaei P, et al. Clinical results of vaccine therapy for cancer: learning from history for improving the future. Adv Cancer Res 2006; 95:147–202. 19. Uyl-de Groot CA, Vermorken JB, Hanna MG Jr., et al. Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits. Vaccine 2005; 23(17–18):2379–2387. 20. AUA 2007, Poster presentation # 94680: A multicenter, randomized, Phase 3 trial of a novel autologous therapeutic vaccine (vitespen) vs. observation as adjuvant therapy in patients at high risk of recurrence after nephrectomy for renal cell carcinoma. 21. Jocham D, Richter A, Hoffmann L, et al. Adjuvant autologous renal tumour cell vaccine and risk of tumour progression in patients with renal-cell carcinoma after radical nephrectomy: phase III, randomised controlled trial. Lancet 2004; 363(9409):594–599. 22. Doehn C., Richter A., Theodor R, et al. Deutscher Krebskongress. Berlin, 22.- 26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. Doc OP285: Prolongation of progression-free and overall survival following an adjuvant vaccination with Reniale 1 in patients with non-metastatic renal cell carcinoma: Secondary analysis of a multicenter phase-III. 23. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol 2006; 24(19):3089–3094. 24. Dendreon. Dendreon’s Second Randomized Phase 3 D9902A Trial of Provenge Extends Survival in Patients with Advanced Prostate Cancer. Press Release, Oct. 31, 2005. Available at: http://investor.dendreon.com/ReleaseDetail.cfm? ReleaseID¼178106&Header¼News. Accessed 1/15/2007. 25. Favrille announces interim analysis of secondary endpoint from pivotal phase III clinical trial of Favld following Rituxan. Favrille Press Release dated November 14, 2006 [cited 20 Apr 2007]. Available at: http://www.favrille.com. Accessed 5/31/2007. 26. Hurvitz S, Timmerman J. Recombinant, tumour-derived idiotype vaccination for indolent B cell non-Hodgkin’s lymphomas: a focus on Favld. Expert Opin Biol Ther 2005; 5(6):841–852. Accessed 5/31/2007. 27. Data Safety Monitoring Board recommends continuation of MyVax 1 personalized immunotherapy phase III trial after second interim analysis. Press release dated July 27, 2006 [cited 10 April 2007]. Available at: www.genitope.com. Accessed 5/31/2007. 28. Biomira. Biomira announces final Phase 2b survival results of Stimuvax(R) (formerly known as BLP25 Liposome Vaccine) trial in patients with non-small cell lung cancer. Press Release, April 28, 2006. Available at: http://www.biomira.com/news/ availableYears/?id=849188. 29. Butts C, Murray N, Maksymiuk A, et al. Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer. J Clin Oncol 2005; 23(27):6674–6681. 30. R&D Insight, Wolters Kluwer Health. Available at: http://bi.adisinsight.com. Accessed 9/19/2007. 31. Finke L, Wentworth K, Blumenstein B, et al. Lessons from Randomized Phase III Studies with Active Cancer Immunotherapies: outcomes from the 2006 Meeting of the Cancer Vaccine Consortium (CVC) 9–11 Nov, 2006, Washington, DC. 32. Hoos A, Parmiani G, Hege K, et al. A clinical development paradigm for cancer vaccines and related biologics. J Immunother 2007; 30(1):1–15.
Page 1 and 2:
Translational Medicine Series 6 Can
Page 3 and 4:
TRANSLATIONAL MEDICINE SERIES 1. Pr
Page 5 and 6:
Informa Healthcare USA, Inc. 52 Van
Page 8 and 9:
Preface Throughout the last 20 year
Page 10 and 11:
Preface vii Table 1 A Diverse Techn
Page 12 and 13:
Preface . . . . v Contributors . .
Page 14 and 15:
Contributors Pedro Alves Ludwig Ins
Page 16 and 17:
1 Factoring in Antigen Processing i
Page 18 and 19:
Factoring in Antigen Processing in
Page 20 and 21:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47: 2 Outlining the Gap Between Preclin
Page 48 and 49: Preclinical Models and Clinical Sit
Page 50 and 51: Table 1 Examples of Preclinical Act
Page 68: Preclinical Models and Clinical Sit
Page 71 and 72: 56 Srinivasan disease agents. Garda
Page 73 and 74: 58 Srinivasan expressing various kn
Page 75 and 76: 60 Srinivasan The above-mentioned a
Page 77 and 78: 62 Srinivasan (69). In another stud
Page 79 and 80: 64 Srinivasan patients with prostat
Page 81 and 82: 66 Srinivasan 33. Salgia R, Lynch T
Page 83 and 84: 68 Srinivasan 67. Werness BA, Levin
Page 85 and 86: 70 Teofilovici and Wentworth In 190
Page 87 and 88: 72 Teofilovici and Wentworth conduc
Page 89 and 90: 74 Teofilovici and Wentworth Lipono
Page 91 and 92: 76 Teofilovici and Wentworth (best
Page 93 and 94: 78 Teofilovici and Wentworth nature
Page 95: 80 Teofilovici and Wentworth In the
Page 99 and 100: 84 Luptrawan et al. Dendritic cells
Page 101 and 102: 86 Luptrawan et al. of cancer cells
Page 103 and 104: 88 Luptrawan et al. NK cells can ki
Page 105 and 106: 90 Luptrawan et al. Figure 2 Repres
Page 107 and 108: 92 Luptrawan et al. state (50). Pat
Page 109 and 110: 94 Luptrawan et al. ability of TIL
Page 111 and 112: 96 Luptrawan et al. Figure 4 Drug s
Page 113 and 114: 98 Luptrawan et al. Figure 6 Tumor
Page 115 and 116: Table 1 Summary of results of phase
Page 117 and 118: 102 Luptrawan et al. Table 1 Summar
Page 119 and 120: 104 Luptrawan et al. antigens (84,8
Page 121 and 122: 106 Luptrawan et al. 30. Ranges GE,
Page 123 and 124: 108 Luptrawan et al. 66. Dunn GP, B
Page 125 and 126: 110 Schroter and Minev proteins (2,
Page 127 and 128: 112 Schroter and Minev tumor-challe
Page 129 and 130: 114 Schroter and Minev Table 1 Inve
Page 131 and 132: 116 Schroter and Minev Table 1 Inve
Page 133 and 134: 118 Schroter and Minev demonstrated
Page 135 and 136: 120 Schroter and Minev loaded MART-
Page 137 and 138: 122 Schroter and Minev illustrate t
Page 139 and 140: 124 Schroter and Minev 4. Heemels M
Page 141 and 142: 126 Schroter and Minev 42. Minev BR
Page 143 and 144: 128 Schroter and Minev 74. Restifo
Page 146 and 147:
7 Multimodality Immunization Approa
Page 148 and 149:
Multimodality Immunization Approach
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Figure 5.1 Immunohistochemical char
Page 164 and 165:
Figure 8.5 A schematic representati
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
8 Bidirectional Bedside Lab Bench P
Page 172 and 173:
Development of Novel Immunotherapeu
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
9 Diagnostic Approaches for Selecti
Page 202 and 203:
Diagnostic Approaches to Maximize T
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222:
Page 225 and 226:
206 Index Antigenic peptides degrad
Page 227 and 228:
208 Index Chromogens, enzymatic act
Page 229 and 230:
210 Index Freund’s adjuvants. See
Page 231 and 232:
212 Index Langerhans cells, 133, 13
Page 233 and 234:
214 Index [Peptide vaccines] invest
Page 235 and 236:
216 Index TCRL. See TCR-like immuno
Page 238:
Oncology and Immunology about the b
show all

Download File - JOHN J. HADDAD, Ph.D.

Create successful ePaper yourself

Delete template?

Save as template?