Phase I/IIa clinical trial of a novel hTERT peptide vaccine in men with metastatic hormone-naive prostate cancer

Cancer Immunology, Immunotherapy

Volumn 66, Issue 7, 2017, Pages 891-901

  Lilleby, Wolfgang ^a   Gaudernack, Gustav ^a,b   Brunsvig, Paal F ^a   Vlatkovic, Ljiljana ^a   Schulz, Melanie ^a   Mills, Kate ^a   Hole, Knut Håkon ^a   Inderberg, Else Marit ^a  

^a OSLO UNIVERSITY HOSPITAL   (Norway)

^b Ultimovacs AS   (Norway)

Author keywords

Cancer vaccine; hTERT; Immune response; Prostate cancer

Indexed keywords

ANTIHISTAMINIC AGENT; CANCER VACCINE; GAMMA INTERFERON; HYDROCORTISONE; PEPTIDE VACCINE; PROSTATE SPECIFIC ANTIGEN; SARGRAMOSTIM; UNCLASSIFIED DRUG; UV 1; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; PEPTIDE FRAGMENT; RECOMBINANT PROTEIN; SUBUNIT VACCINE; TELOMERASE; UV1 VACCINE;

ADULT; AGED; ANAPHYLAXIS; ANDROGEN DEPRIVATION THERAPY; ANXIETY DISORDER; ARTHRALGIA; ARTHRITIS; ARTHROPOD STING; ARTICLE; BACKACHE; BALANCE DISORDER; BONE METASTASIS; BRONCHITIS; CANCER IMMUNIZATION; CLINICAL ARTICLE; CLINICAL OUTCOME; COGNITIVE DEFECT; CONFORMAL RADIOTHERAPY; CONTROLLED STUDY; COUGHING; CYSTITIS; CYSTITIS NONINFECTIVE; CYTOKINE RELEASE; CYTOTOXIC T LYMPHOCYTE; DEFECATION URGENCY; DIARRHEA; DIZZINESS; DRUG DOSE ESCALATION; DRUG SAFETY; DYSURIA; ENZYME LINKED IMMUNOSPOT ASSAY; EYE DISCHARGE; FAINTNESS; FATIGUE; FOLLOW UP; GENERALISED PRURITUS; HAND FOOT SYNDROME; HEART DISEASE; HEART RATE IRREGULAR; HEMATURIA; HEMORRHOID HEMORRHAGE; HERPES ZOSTER; HOT FLUSH; HUMAN; HYPESTHESIA; IMMUNE RESPONSE; INFLUENZA; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE RASH; INSECT STING; ISCHEMIA; JOINT STIFFNESS; LIMB PAIN; LISTLESSNESS; LYMPHEDEMA; MALE; MICTURITION DISORDER; MICTURITION URGENCY; MUSCLE WEAKNESS; MUSCULOSKELETAL PAIN; MUSCULOSKELETAL STIFFNESS; PAIN; PELVIC PAIN; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POLLAKISURIA; PRIORITY JOURNAL; PRODUCTIVE COUGH; PROSTATE CANCER; PRURITUS; RASH; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SKIN INJURY; SLEEP DISORDER; TACHYCARDIA; TENDERNESS; THORAX PAIN; THROMBOCYTOPENIA; URETHRAL PAIN; URINARY TRACT INFECTION; VIRAL GASTROENTERITIS; VOMITING; WOUND; ACTIVE IMMUNIZATION; ADENOCARCINOMA; BLOOD; BONE TUMOR; CLINICAL TRIAL; COHORT ANALYSIS; IMMUNOLOGY; IMMUNOTHERAPY; LYMPH NODE METASTASIS; MIDDLE AGED; NUCLEAR MAGNETIC RESONANCE IMAGING; PATHOLOGY; PROCEDURES; PROSTATIC NEOPLASMS; SECONDARY;

ADENOCARCINOMA; AGED; BONE NEOPLASMS; CANCER VACCINES; COHORT STUDIES; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; IMMUNITY, ACTIVE; IMMUNOTHERAPY; LYMPHATIC METASTASIS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; PEPTIDE FRAGMENTS; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; RECOMBINANT PROTEINS; TELOMERASE; VACCINES, SUBUNIT;

EID: 85017131236     PISSN: 03407004     EISSN: 14320851     Source Type: Journal    
DOI: 10.1007/s00262-017-1994-y     Document Type: Article

References (27)

1. Lilleby W, Hernes E, Wæhre H, Raabe N, Fosså SD (2006) Treatment of hormone-resistant prostate cancer. Tidsskr Nor Laegeforen 126:2798–2801
2. Lilleby W, Narang A, Tafjord G, Vlatkovic L, Russnes KM, Stensvold A, Hole KH, Tran PT, Eilertsen K (2015) Favorable outcomes in locally advanced and node positive prostate cancer patients treated with combined pelvic IMRT and androgen deprivation therapy. Radiat Oncol 10:232–237. doi:10.1186/s13014-015-0540-3
3. Kyte JA (2009) Cancer vaccination with telomerase peptide GV1001. Expert Opin Investig Drugs 18:687–694
4. Su Z, Dannull J, Yang BK et al (2005) Telomerase mRNA-transfected dendritic cells stimulate antigen-specific CD8+ and CD4+ T cell responses in patients with metastatic prostate cancer. J Immunol 174:3798–3807
5. Zanetti M (2017) A second chance for telomerase reverse transcriptase in anticancer immunotherapy. Nat Rev Clin Oncol 14:115–128. doi:10.1038/nrclinonc.2016.67
6. Li J, Li H, Liu J, Feng B, Feng M, Lv B, Cheng S, Yang X (2016) The clinical implications of human telomerase reverse transcriptase expression in grade and prognosis of gliomas: a systematic review and meta-analysis. Mol Neurobiol 53:2887–2893. doi:10.1007/s12035-015-9170-x
7. Shin JS, Foo T, Hong A, Zhang M, Lum T, Solomon MJ, Lee CS (2012) Telomerase expression as a predictive marker of radiotherapy response in rectal cancer. Pathology 44:209–215. doi:10.1097/PAT.0b013e3283511cd5
8. Inderberg-Suso EM, Trachsel S, Lislerud K, Rasmussen AM, Gaudernack G (2012) Widespread CD4+ T cell reactivity to novel hTERT epitopes following vaccination of cancer patients with a single hTERT peptide GV1001. Oncoimmunology 1:670–686. doi:10.4161/onci.20426
9. Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228–247. doi:10.1016/j.ejca.2008.10.026
10. Scher HI, Halabi S, Tannock T et al (2008) Design and endpoints of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone. J Clin Oncol 26:1148–1159
11. Kyte JA, Mu L, Aamdal S et al (2006) Phase I/II trial of melanoma therapy with dendritic cells transfected with autologous tumor-mRNA. Cancer Gene Ther 13:905–918
12. Kyte JA, Kvalheim G, Aamdal S, Saeboe-Larssen S, Gaudernack G (2005) Preclinical full-scale evaluation of dendritic cells transfected with autologous tumor-mRNA for melanoma vaccination. Cancer Gene Ther 12:579–591
13. Suso EM, Dueland S, Rasmussen AM, Vetrhus T, Aamdal S, Kvalheim G, Gaudernack G (2011) hTERT mRNA dendritic cell vaccination: complete response in a pancreatic cancer patient associated with response against several hTERT epitopes. Cancer Immunol Immunother 60:809–818
14. Charo J, Perez C, Buschow C, Jukica A, Czeh M, Blankenstein T (2011) Visualizing the dynamic of adoptively transferred T cells during the rejection of large established tumors. Eur J Immunol 41:3187–3197
15. van Poelgeest MI, Welters MJ, Vermeij R et al (2016) Vaccination against oncoproteins of HPV16 for noninvasive vulvar/vaginal lesions: lesion clearance is related to the strength of the T cell response. Clin Cancer Res 22:2342–2350. doi:10.1158/1078-0432.CCR-15-2594
16. Brunsvig PF, Aamdal S, Gjertsen MK et al (2006) Telomerase peptide vaccination: a phase I/II study in patients with non-small cell lung cancer. Cancer Immunol Immunother 55:1553–1564
17. Kwon ED, Drake CG, Scher HI et al (2014) Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol 15:700–712. doi:10.1016/S1470-2045(14)70189-5
18. Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW (2013) Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the immunotherapy for prostate adenocarcinoma treatment (IMPACT) trial. Urology 81:1297–1302. doi:10.1016/j.urology.2013.01.061
19. Nemunaitis J, Susan N, Rabinowe ND et al (1991) Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. http://products.sanofi.us/Leukine/Leukine.html. Accessed 20 Feb 2017
20. Heidenreich A (2015) New developments in the management of prostate cancer. Oncol Res Treat 38:628. doi:10.1159/000442269
21. Narang AK, Gergis C, Robertson SP et al (2016) Very high-risk localized prostate cancer: outcomes following definitive radiation. Int J Radiat Oncol Biol Phys 94:254–262. doi:10.1016/j.ijrobp.2015.10.056
22. Mercader M, Bodner BK, Moser MT et al. (2001) T cell infiltration of the prostate induced by androgen withdrawal in patients with prostate cancer. Proc Natl Acad Sci 98:14565–14570. doi:10.1073/pnas.251140998
23. Wolchok JD, Hoos A, O’Day S et al (2009) Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Can Res 15:7412–7420
24. Sweeney CJ, Chen YH, Carducci M et al (2015) Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med 373:737–746. doi:10.1056/NEJMoa1503747
25. Brunsvig PF, Kyte JA, Kersten C, Sundstrom S, Moller M, Nyakas M, Hansen GL, Gaudernack G, Aamdal S (2011) Telomerase peptide vaccination in NSCLC: a phase II trial in stage III patients vaccinated after chemoradiotherapy and an 8-year update on a phase I/II trial. Clin Can Res 17:6847–6857
26. Harris TJ, Hipkiss EL, Borzillary S et al (2008) Radiotherapy augments the immune response to prostate cancer in a time-dependent manner. Prostate 68:1319–1329. doi:10.1002/pros.20794
27. Nesslinger NJ, Sahota RA, Stone B et al (2007) Standard treatments induce antigen-specific immune responses in prostate cancer. Clin Cancer Res 13:1493–1502