A National Multicenter Phase 2 Study of Prostate-specific Antigen (PSA) Pox Virus Vaccine with Sequential Androgen Ablation Therapy in Patients with PSA Progression: ECOG 9802

European Urology

Volumn 68, Issue 3, 2015, Pages 365-371

  DiPaola, Robert S ^a   Chen, Yu Hui ^b   Bubley, Glenn J ^c   Stein, Mark N ^a   Hahn, Noah M ^d   Carducci, Michael A ^e   Lattime, Edmund C ^a   Gulley, James L ^f   Arlen, Philip M ^f   Butterfield, Lisa H ^g   Wilding, George ^h  

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

^b DANA FARBER CANCER INSTITUTE   (United States)

^c BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^d INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e JOHNS HOPKINS UNIVERSITY   (United States)

^f NATIONAL CANCER INSTITUTE   (United States)

^g UNIVERSITY OF PITTSBURGH   (United States)

^h UNIVERSITY OF WISCONSIN   (United States)

Author keywords

Pox virus; Prostate cancer; PSA; Vaccine

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BICALUTAMIDE; BILIRUBIN; CANCER VACCINE; CREATININE; GONADORELIN AGONIST; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; PROSTATE SPECIFIC ANTIGEN; RILIMOGENE GALVACIREPVEC; RILIMOGENE GLAFOLIVEC; ANTIANDROGEN; KALLIKREIN; KALLIKREIN-RELATED PEPTIDASE 3, HUMAN;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALLERGY; ANDROGEN THERAPY; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BONE PAIN; CANCER GROWTH; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CHILL; CREATININE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; ERYTHEMA MULTIFORME; FATIGUE; FEVER; FLATULENCE; FLUSHING; HAND FOOT SYNDROME; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPERNATREMIA; INJECTION SITE REACTION; JOINT EFFUSION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MYALGIA; NAUSEA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; POXVIRIDAE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; TREATMENT RESPONSE; WEIGHT REDUCTION; AGED; BLOOD; CLINICAL TRIAL; DISEASE COURSE; FOWLPOX VIRUS; IMMUNOLOGY; MULTIMODALITY CANCER THERAPY; PROSTATECTOMY; PROSTATIC NEOPLASMS; VACCINIA VIRUS;

AGED; ANDROGEN ANTAGONISTS; CANCER VACCINES; COMBINED MODALITY THERAPY; DISEASE PROGRESSION; FOWLPOX VIRUS; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; KALLIKREINS; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATECTOMY; PROSTATIC NEOPLASMS; VACCINIA VIRUS;

EID: 84940611885     PISSN: 03022838     EISSN: 18737560     Source Type: Journal    
DOI: 10.1016/j.eururo.2014.12.010     Document Type: Article

References (19)

1. S.M. Alibhai, M. Duong-Hua, R. Sutradhar, and et al. Impact of androgen deprivation therapy on cardiovascular disease and diabetes J Clin Oncol 27 2009 3452 3458
2. J.M. Holzbeierlein, M.D. McLaughlin, and J.B. Thrasher Complications of androgen deprivation therapy for prostate cancer Curr Opin Urol 14 2004 177 183
3. J.Y. Bruce, J.M. Lang, D.G. McNeel, and G. Liu Current controversies in the management of biochemical failure in prostate cancer Clin Adv Hematol Oncol 10 2012 716 722
4. P.M. Arlen, H.L. Kaufman, and R.S. DiPaola Pox viral vaccine approaches Semin Oncol 32 2005 549 555
5. E. Paoletti Applications of pox virus vectors to vaccination: an update Proc Natl Acad Sci U S A 93 1996 11349 11353
6. H.L. Kaufman, W. Wang, J. Manola, and et al. Phase II randomized study of vaccine treatment of advanced prostate cancer (E7897): a trial of the Eastern Cooperative Oncology Group J Clin Oncol 22 2004 2122 2132
7. P.W. Kantoff, T.J. Schuetz, B.A. Blumenstein, and 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 28 2010 1099 1105
8. R.A. Madan, J.L. Gulley, T. Fojo, and W.L. Dahut Therapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progression Oncologist 15 2010 969 975
9. C.G. Drake, E. Jaffee, and D.M. Pardoll Mechanisms of immune evasion by tumors Adv Immunol 90 2006 51 81
10. A.A. Hurwitz, P. Yanover, M. Markowitz, J.P. Allison, and E.D. Kwon Prostate cancer: advances in immunotherapy BioDrugs 17 2003 131 138
11. M. Mercader, B.K. Bodner, M.T. Moser, and et al. T cell infiltration of the prostate induced by androgen withdrawal in patients with prostate cancer Proc Natl Acad Sci U S A 98 2001 14565 14570
12. J. Gulley, A.P. Chen, W. Dahut, and et al. Phase I study of a vaccine using recombinant vaccinia virus expressing PSA (rV-PSA) in patients with metastatic androgen-independent prostate cancer Prostate 53 2002 109 117
13. E.J. Small, D.M. Reese, B. Um, S. Whisenant, S.C. Dixon, and W.D. Figg Therapy of advanced prostate cancer with granulocyte macrophage colony-stimulating factor Clin Cancer Res 5 1999 1738 1744
14. P.W. Kantoff, C.S. Higano, N.D. Shore, and et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer N Engl J Med 363 2010 411 422
15. W.D. Stein, J.L. Gulley, J. Schlom, and et al. 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 17 2011 907 917
16. J.L. Gulley, R.A. Madan, and J. Schlom Impact of tumour volume on the potential efficacy of therapeutic vaccines Curr Oncol 18 2011 e150 e157
17. M. Hussain, C.M. Tangen, C. Higano, and et al. Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162) J Clin Oncol 24 2006 3984 3990
18. M. Hussain, C.M. Tangen, D.L. Berry, and et al. Intermittent versus continuous androgen deprivation in prostate cancer N Engl J Med 368 2013 1314 1325
19. C.J. Keto, W.J. Aronson, M.K. Terris, and et al. Detectable prostate-specific antigen nadir during androgen-deprivation therapy predicts adverse prostate cancer-specific outcomes: results from the SEARCH database Eur Urol 65 2014 620 627