Samarium-153-EDTMP (Quadramet®) with or without vaccine in metastatic castration-resistant prostate cancer: A randomized Phase 2 trial

Oncotarget

Volumn 7, Issue 42, 2016, Pages 69014-69023

  Heery, Christopher R ^a   Madan, Ravi A ^a   Stein, Mark N ^b   Stadler, Walter M ^c   Di Paola, Robert S ^b,e   Rauckhorst, Myrna ^a   Steinberg, Seth M ^a   Marté, Jennifer L ^a   Chen, Clara C ^d   Grenga, Italia ^a   Donahue, Renee N ^a   Jochems, Caroline ^a   Dahut, William L ^a   Schlom, Jeffrey ^a   Gulley, James L ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

^b RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

^c UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^d NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING   (United States)

^e UNIVERSITY OF KENTUCKY   (United States)

Author keywords

Cancer immunotherapy; Prostate cancer; Quadramet ; Radionuclide; Therapeutic vaccine

Indexed keywords

LEXIDRONAM SAMARIUM SM 153; PROSTATE SPECIFIC ANTIGEN; RILIMOGENE GALVACIREPVEC; CANCER VACCINE; ORGANOMETALLIC COMPOUND; ORGANOPHOSPHORUS COMPOUND; RADIOISOTOPE; RADIOPHARMACEUTICAL AGENT; SAMARIUM SM-153 LEXIDRONAM;

ADULT; AGED; ARTICLE; CANCER GROWTH; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; HEMATOLOGIC DISEASE; HUMAN; INJECTION SITE REACTION; MALE; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; MULTICENTER STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TUMOR IMMUNITY; BLOOD; BONE TUMOR; CLINICAL TRIAL; DISEASE EXACERBATION; DISEASE FREE SURVIVAL; ELECTRON; IMMUNOTHERAPY; METABOLISM; METASTASIS; MIDDLE AGED; OSTEOBLAST; PHENOTYPE; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; BETA PARTICLES; BONE NEOPLASMS; CANCER VACCINES; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; HUMANS; IMMUNOTHERAPY; MALE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOMETALLIC COMPOUNDS; ORGANOPHOSPHORUS COMPOUNDS; OSTEOBLASTS; PHENOTYPE; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; RADIOISOTOPES; RADIOPHARMACEUTICALS; TREATMENT OUTCOME;

EID: 85011716095     PISSN: None     EISSN: 19492553     Source Type: Journal    
DOI: 10.18632/ONCOTARGET.10883     Document Type: Article

References (33)

1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015; 65:5-29
2. Sartor O, Reid RH, Bushnell DL, Quick DP, Ell PJ. Safety and efficacy of repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain. Cancer. 2007; 109:637-643
3. Serafini AN, Houston SJ, Resche I, Quick DP, Grund FM, Ell PJ, Bertrand A, Ahmann FR, Orihuela E, Reid RH, Lerski RA, Collier BD, McKillop JH, et al. Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam:a double-blind placebo-controlled clinical trial. J Clin Oncol. 1998; 16:1574-1581
4. Madan RA, Arlen PM, Mohebtash M, Hodge JW, Gulley JL. Prostvac-VF: a vector-based vaccine targeting PSA in prostate cancer. Expert Opin Investig Drugs. 2009; 18:1001-1011
5. Gulley J, Chen AP, Dahut W, Arlen PM, Bastian A, Steinberg SM, Tsang K, Panicali D, Poole D, Schlom J, Michael Hamilton J. Phase I study of a vaccine using recombinant vaccinia virus expressing PSA (rV-PSA) in patients with metastatic androgen-independent prostate cancer. Prostate. 2002; 53:109-117
6. Gulley JL, Arlen PM, Madan RA, Tsang KY, Pazdur MP, Skarupa L, Jones JL, Poole DJ, Higgins JP, Hodge JW, Cereda V, Vergati M, Steinberg SM, et al. Immunologic and prognostic factors associated with overall survival employing a poxviralbased PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother. 2010; 59:663-674
7. Gulley JL, Madan RA, Tsang KY, Jochems C, Marte JL, Farsaci B, Tucker JA, Hodge JW, Liewehr DJ, Steinberg SM, Heery CR, Schlom J. Immune impact induced by PROSTVAC (PSA-TRICOM), a therapeutic vaccine for prostate cancer. Cancer Immunol Res. 2014; 2:133-141
8. KantoffPW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, et al. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010; 28:1099-1105
9. Gulley JL, Arlen PM, Bastian A, Morin S, Marte J, Beetham P, Tsang KY, Yokokawa J, Hodge JW, Menard C, Camphausen K, Coleman CN, Sullivan F, et al. Combining a recombinant cancer vaccine with standard definitive radiotherapy in patients with localized prostate cancer. Clin Cancer Res. 2005; 11:3353-3362
10. Lechleider RJ, Arlen PM, Tsang KY, Steinberg SM, Yokokawa J, Cereda V, Camphausen K, Schlom J, Dahut WL, Gulley JL. Safety and immunologic response of a viral vaccine to prostate-specific antigen in combination with radiation therapy when metronomic-dose interleukin 2 is used as an adjuvant. Clin Cancer Res. 2008; 14:5284-5291
11. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 363:711-723
12. KantoffPW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010; 363:411-422
13. Kim JW, Bilusic M, Heery CJ, Madan RA. Therapeutic cancer vaccines in prostate cancer: the quest for intermediate markers of response. Cancers (Basel). 2012; 4:1229-1246
14. Kim JW, Madan RA, Gulley JL. Initial PSA oscillations precede prolonged stable disease in a patient treated with a therapeutic cancer vaccine. Clin Genitourin Cancer. 2012; 10:43-46
15. Stein WD, Gulley JL, Schlom J, Madan RA, Dahut W, Figg WD, Ning YM, Arlen PM, Price D, Bates SE, Fojo T. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clin Cancer Res. 2011; 17:907-917
16. Gulley JL. Therapeutic vaccines: the ultimate personalized therapy? Hum Vaccin Immunother. 2013; 9:219-221
17. Heery CR, Ibrahim NK, Arlen PM, Mohebtash M, Murray JL, Koenig K, Madan RA, McMahon S, Marte JL, Steinberg SM, Donahue RN, Grenga I, Jochems C, et al. Docetaxel alone or in combination with a therapeutic cancer vaccine (PANVAC) in patients with metastatic breast cancer: a randomized clinical trial. JAMA Oncol. 2015; 1:1087-1095
18. Kroemer G, Galluzzi L, Kepp O, Zitvogel L. Immunogenic cell death in cancer therapy. Annu Rev Immunol. 2013; 31:51-72
19. Zitvogel L, Kepp O, Senovilla L, Menger L, Chaput N, Kroemer G. Immunogenic tumor cell death for optimal anticancer therapy: the calreticulin exposure pathway. Clin Cancer Res. 2010; 16:3100-3104
20. Gameiro SR, Ardiani A, Kwilas A, Hodge JW. Radiationinduced survival responses promote immunogenic modulation to enhance immunotherapy in combinatorial regimens. Oncoimmunology. 2014; 3:e28643
21. Hodge JW, Kwilas A, Ardiani A, Gameiro SR. Attacking malignant cells that survive therapy: Exploiting immunogenic modulation. Oncoimmunology. 2013; 2:e26937
22. Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, et al. 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. 2014; 15:700-712
23. Chakraborty M, Wansley EK, Carrasquillo JA, Yu S, Paik CH, Camphausen K, Becker MD, Goeckeler WF, Schlom J, Hodge JW. The use of chelated radionuclide (samarium-153-ethylenediaminetetramethylenephosphonate) to modulate phenotype of tumor cells and enhance T cell-mediated killing. Clin Cancer Res. 2008; 14:4241-4249
24. Noman MZ, Desantis G, Janji B, Hasmim M, Karray S, Dessen P, Bronte V, Chouaib S. PD-L1 is a novel direct target of HIF-1alpha, and its blockade under hypoxia enhanced MDSC-mediated T cell activation. J Exp Med. 2014; 211:781-790
25. Chakraborty M, Gelbard A, Carrasquillo JA, Yu S, Mamede M, Paik CH, Camphausen K, Schlom J, HodgeJW. Use of radiolabeled monoclonal antibody to enhance vaccine-mediated antitumor effects. Cancer Immunol Immunother. 2008; 57:1173-1183
26. Grayson JM, Harrington LE, Lanier JG, Wherry EJ, Ahmed R. Differential sensitivity of naive and memory CD8+ T cells to apoptosis in vivo. J Immunol. 2002; 169:3760-3770
27. Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castrationresistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014; 15:1397-1406
28. Johns WD, Garnick MB, Kaplan WD. Leuprolide therapy for prostate cancer. An association with scintigraphic "flare" on bone scan. Clin Nucl Med. 1990; 15:485-487
29. Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, Figg WD, Freidlin B, Halabi S, Hudes G, Hussain M, Kaplan R, Myers C, et al. Eligibility and response guidelines for phase II clinical trials in androgenindependent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol. 1999; 17:3461-3467
30. Simon RM, Steinberg SM, Hamilton M, Hildesheim A, Khleif S, Kwak LW, Mackall CL, Schlom J, Topalian SL, Berzofsky JA. Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J Clin Oncol. 2001; 19:1848-1854
31. Terasawa H, Tsang KY, Gulley J, Arlen P, Schlom J. Identification and characterization of a human agonist cytotoxic T-lymphocyte epitope of human prostate-specific antigen. Clin Cancer Res. 2002; 8:41-53
32. Heery CR, Singh BH, Rauckhorst M, Marte JL, Donahue RN, Grenga I, Rodell TC, Dahut W, Arlen PM, Madan RA, Schlom J, Gulley JL. Phase I trial of a yeastbased therapeutic cancer vaccine (GI-6301) targeting the transcription factor brachyury. Cancer Immunol Res. 2015; 3:1248-1256
33. Huang J, Jochems C, Talaie T, Anderson A, Jales A, Tsang KY, Madan RA, Gulley JL, Schlom J. Elevated serum soluble CD40 ligand in cancer patients may play an immunosuppressive role. Blood. 2012; 120:3030-3038