Clinical evaluation of therapeutic cancer vaccines

Human Vaccines and Immunotherapeutics

Volumn 9, Issue 5, 2013, Pages 1049-1057

  Ogi, Chizuru ^a   Aruga, Atsushi ^a  

^a TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

Author keywords

Cancer; Clinical trials; Immunotherapy; Phase III; Prognostic factor; Regulatory science; Therapeutic vaccine

Indexed keywords

ALGENPANTUCEL L; BCG VACCINE; BELAGENPUMATUCEL L; CANCER VACCINE; CYCLOPHOSPHAMIDE; DACARBAZINE; DCVAX BRAIN; DENDRITIC CELL VACCINE; EMEPEPIMUT S; FALIMAREV; GASTRIN; GEMCITABINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HYBRICELL; LYMPHOMA VACCINE; M VAX; MELANOMA VACCINE; MITUMOMAB; MITUMPROTIMUT T; NELIPEPIMUT S; ONAMELATUCEL L; PLACEBO; RACOTUMOMAB; RITUXIMAB; SIPULEUCEL T; SPECIFID; TERTOMOTIDE; THERATOPE; TUMOR CELL VACCINE; UNCLASSIFIED DRUG; VELIMOGENE ALIPLASMID; VITESPEN;

ADJUVANT THERAPY; ANTIBODY RESPONSE; ARTICLE; BREAST CANCER; BREAST METASTASIS; CANCER PROGNOSIS; CANCER STAGING; COLORECTAL CANCER; DRUG APPROVAL; DRUG EFFICACY; DRUG TREATMENT FAILURE; EVENT FREE SURVIVAL; FOLLICULAR LYMPHOMA; GLIOBLASTOMA; HUMAN; IMMUNOLOGICAL TOLERANCE; KIDNEY CARCINOMA; KIDNEY METASTASIS; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; MELANOMA; METASTATIC MELANOMA; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 3 CLINICAL TRIAL (TOPIC); PROSTATE CANCER; RECURRENCE FREE SURVIVAL; TUMOR VOLUME;

CANCER; CLINICAL TRIALS; IMMUNOTHERAPY; KEYWORDS:THERAPEUTIC VACCINE; PHASE III; PROGNOSTIC FACTOR; REGULATORY SCIENCE;

CANCER VACCINES; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; HUMANS; IMMUNOTHERAPY; NEOPLASMS; TREATMENT OUTCOME;

EID: 84878786666     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.23917     Document Type: Article

References (47)

1. FDA's homepage Vaccines, Blood & Biologics, Cellular & Gene Therapy Products, Approved Products. Available from http://www.fda.gov/ BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012. htm
2. World's First Therapeutic Vaccine for Brain Cancer Commercially Available to Patients in Switzerland. Northwest Biotherapeutics, Inc. press release dated 9 July 2007.
3. Brazilian Scientist creates one of the first commercially available vaccine against cancer in the world. Genoa Biotechnologia S.A. News retrieved 25 October 2012.
4. Melanoma Vaccine - AVAX Technologies. Adis International Ltd. Biodrugs 2003; 17:69-72.
5. Randazzo M, Terness P, Opelz G, Kleist C. Active-specific immunotherapy of human cancers with the heat shock protein Gp96-revisited. Int J Cancer 2012; 130:2219-31; PMID:22052568; http://dx.doi.org/10.1002/ijc.27332.
6. González G, Lage A, Grombel T, Rodriguez G, Garcia B, Cuevas A, et al. CIMAvax-EGF: A novel therapeutic vaccine for advanced lung cancer. Biotecnol Apl 2009; 26:345-8.
7. Uyl-de Groot CA, Vermorken JB, Hanna MG Jr., Verboom P, Groot MT, Bonsel GJ, et al. Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits. Vaccine 2005; 23:2379-87; PMID:15755632; http://dx.doi.org/10.1016/j.vaccine.2005.01. 015.
8. Berd D, Sato T, Maguire HC Jr., Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol 2004; 22:403-15; PMID:14691123; http://dx.doi.org/10.1200/ JCO.2004.06.043.
9. Sondak VK, Sabel MS, Mulé JJ. Allogeneic and autologous melanoma vaccines: where have we been and where are we going? Clin Cancer Res 2006; 12:2337s-41s; PMID:16609055; http://dx.doi.org/10.1158/1078-0432.CCR-05-2555.
10. Therion Reports Results of Phase 3 PANVAC-VF Trial and Announces Plans for Company Sale. PR Newswire 28 June available from http://www.prnewswire.com/ news-releases/therion-reports-results-of-phase-3-panvac-vf-trial-and-announces- plans-for-company-sale-56997582.html
11. Bedikian AY, Del Vecchio M. Allovectin-7 therapy in metastatic melanoma. Expert Opin Biol Ther 2008; 8:839-44; PMID:18476795; http://dx.doi.org/10.1517/ 14712598.8.6.839.
12. Gilliam AD, Watson SA. G17DT: an antigastrin immunogen for the treatment of gastrointestinal malignancy. Expert Opin Biol Ther 2007; 7:397-404; PMID:17309331; http://dx.doi.org/10.1517/14712598.7.3.397.
13. Finke LH, Wentworth K, Blumenstein B, Rudolph NS, Levitsky H, Hoos A. Lessons from randomized phase III studies with active cancer immunotherapies - outcomes from the 2006 meeting of the Cancer Vaccine Consortium (CVC). Vaccine 2007; 25(Suppl 2):B97-109; PMID:17916465; http://dx.doi.org/10.1016/j.vaccine. 2007.06.067.
14. Testori A, Richards J, Whitman E, Mann GB, Lutzky J, Camacho L, et al.; C-100-21 Study Group. Phase III comparison of vitespen, an autologous tumor-derived heat shock protein gp96 peptide complex vaccine, with physician's choice of treatment for stage IV melanoma: the C-100-21 Study Group. J Clin Oncol 2008; 26:955-62; PMID:18281670; http://dx.doi.org/10.1200/JCO.2007.11. 9941.
15. Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, et al.; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet 2008; 372:145-54; PMID:18602688; http://dx.doi.org/10.1016/S0140-6736(08)60697-2.
16. Pharmexa stops one of two Phase III trials. Drugs.com May 13, 2008 available from http://www.drugs.com/news/pharmexa-stops-one-two-phase-iii- trials-8180.html
17. OncoTherapy Science, Inc. Press release dated Feb. 29, 2012.
18. Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono. Oncothyreon Inc. Press release dated Mar. 23, 2010.
19. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al.; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363:411-22; PMID:20818862; http://dx.doi.org/10.1056/NEJMoa1001294.
20. Freedman A, Neelapu SS, Nichols C, Robertson MJ, Djulbegovic B, Winter JN, et al. Placebo-controlled phase III trial of patient-specific immunotherapy with mitumprotimut-T and granulocyte-macrophage colony-stimulating factor after rituximab in patients with follicular lymphoma. J Clin Oncol 2009; 27:3036-43; PMID:19414675; http://dx.doi.org/10.1200/JCO.2008.19.8903.
21. Schuster SJ, Neelapu SS, Gause BL, Janik JE, Muggia FM, Gockerman JP, et al. Vaccination with patient-specific tumor-derived antigen in first remission improves disease-free survival in follicular lymphoma. J Clin Oncol 2011; 29:2787-94; PMID:21632504; http://dx.doi.org/10.1200/JCO.2010.33.3005.
22. Fernandes LE, Gabri MR, Guthmann MD, Gomez RE, Gold S, Fainboim L, et al. NGcGM3 Ganglioside: a privileged target for cancer vaccines. Clinical and Development Immunology 2010, Article ID814397, 8 pages doi:10.1155/2010/814397.
23. Giaccone G, Debruyne C, Felip E, Chapman PB, Grant SC, Millward M, et al. Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study). J Clin Oncol 2005; 23:6854-64; PMID:16192577; http://dx.doi.org/10.1200/JCO.2005. 17.186.
24. Schuster SJ, Neelapu SS, Gause BL, Muggia FM, Gockerman JP, Sotomayor EM, et al. Idiotype accine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results. J Clin Oncol 2009; 27:(suppl; abstr2).
25. Randazzo M, Terness P, Opelz G, Kleist C. Active-specific immunotherapy of human cancers with the heat shock protein Gp96-revisited. Int J Cancer 2012; 130:2219-31; PMID:22052568; http://dx.doi.org/10.1002/ijc.27332.
26. Dalgleish AG. Therapeutic cancer vaccines: why so few randomised phase III studies reflect the initial optimism of phase II studies. Vaccine 2011; 29:8501-5; PMID:21933695; http://dx.doi.org/10.1016/j.vaccine.2011.09.012.
27. Hoos A, Britten CM, Huber C, O'Donnell-Tormey J. A methodological framework to enhance the clinical success of cancer immunotherapy. Nat Biotechnol 2011; 29:867-70; PMID:21997622; http://dx.doi.org/10.1038/nbt.2000.
28. Hsueh EC, Morton DL. Antigen-based immunotherapy of melanoma: Canvaxin therapeutic polyvalent cancer vaccine. Semin Cancer Biol 2003; 13:401-7; PMID:15001158; http://dx.doi.org/10.1016/j.semcancer.2003.09.003.
29. Galon J, Pagès F, Marincola FM, Thurin M, Trinchieri G, Fox BA, et al. The immune score as a new possible approach for the classification of cancer. J Transl Med 2012; 10:1; PMID:22214470; http://dx.doi.org/10.1186/1479- 5876-10-1.
30. Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009; 115:3670-9; PMID:19536890; http://dx.doi.org/10.1002/cncr. 24429.
31. Redfern CH, Guthrie TH, Bessudo A, Densmore JJ, Holman PR, Janakiraman N, et al. Phase II trial of idiotype vaccination in previously treated patients with indolent non-Hodgkin's lymphoma resulting in durable clinical responses. J Clin Oncol 2006; 24:3107-12; PMID:16754937; http://dx.doi.org/10.1200/JCO.2005. 04.4289.
32. Koç ON, Redfern C, Wiernik PH, Rosenfelt F, Winter JN, Carter WD, et al. A phase 2 trial of immunotherapy with mitumprotimut-T (Id-KLH) and GM-CSF following rituximab in follicular B-cell lymphoma. J Immunother 2010; 33:178-84; PMID:20145546; http://dx.doi.org/10.1097/CJI.0b013e3181bfcea1.
33. Chapman PB, Williams L, Salibi N, Hwu WJ, Krown SE, Livingston PO. A phase II trial comparing five dose levels of BEC2 anti-idiotypic monoclonal antibody vaccine that mimics GD3 ganglioside. Vaccine 2004; 22:2904-9; PMID:15246627; http://dx.doi.org/10.1016/j.vaccine.2003.12.028.
34. Brett BT, Smith SC, Bouvier CV, Michaeli D, Hochhauser D, Davidson BR, et al. Phase II study of anti-gastrin-17 antibodies, raised to G17DT, in advanced pancreatic cancer. J Clin Oncol 2002; 20:4225-31; PMID:12377966; http://dx.doi.org/10.1200/JCO.2002.11.151.
35. Shapiro J, Marshall J, Karasek P, Figer A, Oette H, Couture F, et al. G17DT+gemcitabine [Gem] versus placebo+Gem in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: Results of a randomized, double-blind, multinational, multicenter study. J Clin Oncol (ASCO Meeting Abstracts) 2005; 23(16S) Part I of II (June 1 Supplement).
36. Lee ST, Jiang YF, Park KU, Woo AF, Neelapu SS. BiovaxID: a personalized therapeutic cancer vaccine for non-Hodgkin's lymphoma. Expert Opin Biol Ther 2007; 7:113-22; PMID:17150023; http://dx.doi.org/10.1517/14712598.7.1.113.
37. Shuster SJ, Neelapu SS, Gause BL, Muggia FM, Gockerman JP, Sotomayor EM, et al. Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission. ASCO2009 Annual Meeting.
38. Madan RA, Bilusic M, Heery C, Schlom J, Gulley JL. Clinical evaluation of TRICOM vector therapeutic cancer vaccines. Semin Oncol 2012; 39:296-304; PMID:22595052; http://dx.doi.org/10.1053/j.seminoncol.2012.02.010.
39. Mayordomo J, Tres A, Miles D, Finke L, Jenkins H. Long-term follow-up of patients concomitantly treated with hormone therapy in a prospective controlled randomized multicenter clinical study comparing STn-KLH vaccine with KLH control in stage IV breast cancer following first line chemotherapy. [ASCO Meeting Abstracts]. J Clin Oncol 2004; 22(suppl 2603.).
40. Jonasch E, Wood C, Tamboli P, Pagliaro LC, Tu SM, Kim J, et al. Vaccination of metastatic renal cell carcinoma patients with autologous tumour-derived vitespen vaccine: clinical findings. Br J Cancer 2008; 98:1336-41; PMID:18362942; http://dx.doi.org/10.1038/sj.bjc.6604266.
41. McDermott DF, Regan MM, Clark JI, Flaherty LE, Weiss GR, Logan TF, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 2005; 23:133-41; PMID:15625368; http://dx.doi.org/10.1200/JCO.2005. 03.206.
42. Timmerman JM, Vose JM, Czerwinski DK, Weng WK, Ingolia D, Mayo M, et al. Tumor-specific recombinant idiotype immunisation after chemotherapy as initial treatment for follicular non-Hodgkin lymphoma. Leuk Lymphoma 2009; 50:37-46; PMID:19125383; http://dx.doi.org/10.1080/10428190802563355.
43. Small EJ, Fratesi P, Reese DM, Strang G, Laus R, Peshwa MV, et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol 2000; 18:3894-903; PMID:11099318.
44. Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, 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; 24:3089-94; PMID:16809734; http://dx.doi.org/10.1200/JCO.2005.04.5252.
45. Terando AM, Faries MB, Morton DL. Vaccine therapy for melanoma: current status and future directions. Vaccine 2007; 25(Suppl 2):B4-16; PMID:17646038; http://dx.doi.org/10.1016/j.vaccine.2007.06.033.
46. Vergati M, Intrivici C, Huen NY, Schlom J, Tsang KY. Strategies for cancer vaccine development. J Biomed Biotechnol 2010; 2010:596432; PMID:20706612; http://dx.doi.org/10.1155/2010/596432.
47. Genitope Corporation. "Genitope Corporation To Suspend Development Of MyVax(R) Personalized Immunotherapy." Medical News Today. MediLexicon, Intl., 12 Mar. 2008. Web. 10 Jan. 2013. http://www.medicalnewstoday.com/ releases/100258.php