A phase II trial of intraperitoneal EGEN-001, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: A Gynecologic Oncology Group study

Gynecologic Oncology

Volumn 133, Issue 3, 2014, Pages 433-438

  Alvarez, Ronald D ^a   Sill, Michael W ^b   Davidson, Susan A ^c   Muller, Carolyn Y ^d   Bender, David P ^e   Debernardo, Robert L ^f   Behbakht, Kian ^c   Huh, Warner K ^a  

^a UNIVERSITY OF ALABAMA SCHOOL OF MEDICINE   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF NEW MEXICO   (United States)

^e UNIVERSITY OF IOWA   (United States)

^f LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Gene therapy; Ovarian cancer; Phase II trial

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CA 125 ANTIGEN; CHOLESTEROL; EGEN 001; INTERLEUKIN 12; MACROGOL; PLATINUM; POLYMER; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BREAST DISEASE; CANCER RECURRENCE; CANCER RESISTANCE; CANCER SURVIVAL; CHILL; CLINICAL EFFECTIVENESS; CONNECTIVE TISSUE DISEASE; DEHYDRATION; DRUG EFFICACY; DRUG FEVER; DRUG WITHDRAWAL; EAR DISEASE; EYE DISEASE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOMAGNESEMIA; HYPONATREMIA; INFECTION; INNER EAR DISEASE; LEUKOPENIA; LIVER TOXICITY; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAUSEA; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; OUTCOME ASSESSMENT; OVARY CANCER; OVERALL SURVIVAL; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIMARY TUMOR; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SENSORY NEUROPATHY; SIDE EFFECT; SKIN DISEASE; SMALL INTESTINE OBSTRUCTION; THROMBOCYTOPENIA; TREATMENT RESPONSE; UTERINE TUBE CANCER; UTERINE TUBE DISEASE; VOMITING;

GENE THERAPY; OVARIAN CANCER; PHASE II TRIAL;

ADENOCARCINOMA; ADULT; AGED; CARCINOMA, ENDOMETRIOID; CHOLESTEROL; CYSTADENOCARCINOMA, SEROUS; DISEASE-FREE SURVIVAL; DRUG RESISTANCE, NEOPLASM; FALLOPIAN TUBE NEOPLASMS; FEMALE; GENE TRANSFER TECHNIQUES; GENETIC THERAPY; HUMANS; INFUSIONS, PARENTERAL; INTERLEUKIN-12; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS, GLANDULAR AND EPITHELIAL; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PLASMIDS; POLYETHYLENE GLYCOLS; POLYETHYLENEIMINE; TREATMENT OUTCOME;

EID: 84901663487     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2014.03.571     Document Type: Article

References (21)

1. G.M. Mantia-Smaldone, B. Corr, and C.S. Chu Immunotherapy in ovarian cancer Hum Vaccin Immunother 8 2012 1179 1191
2. J.M. Whitworth, and R.D. Alvarez Evaluating the role of IL-12 based therapies in ovarian cancer: a review of the literature Expert Opin Biol Ther 11 2011 751 762
3. D.G. Duda, M. Sunamura, L. Lozonschi, T. Kodama, S.-I. Egawa, and G. Matsumoto et al. Direct in vitro evidence and in vivo analysis of the antiangiogenesis effects of interleukin 12 Cancer Res 60 2000 1111 1116
4. R. Lenzi, R. Edwards, C. June, M.V. Seiden, M.E. Garcia, and M. Rosenblum et al. Phase II study of intraperitoneal recombinant interleukin-12 (rhIL-12) in patients with peritoneal carcinomatosis (residual disease < 1 cm) associated with ovarian cancer or primary peritoneal carcinoma J Transl Med 12 5 2007 66
5. J. Fewell, M. Matar, G. Slobodkin, J. Rice, B. Hovanes, and K. Anwer Synthesis and application of biocompatible non-viral gene delivery system for immunogene therapy of cancer J Control Release 109 2005 288 298
6. J.G. Fewell, J. Rice, M. Matar, E. Brunhoeber, C. Pence, and G. Slobodkin et al. Use of interleukin-12 gene nanocomplexes as a general treatment against disseminated peritoneal malignancies Proc Am Assoc Cancer Res 48 2007 3304
7. J. Fewell, M. Matar, J. Rice, E. Brunhoeber, G. Slobodkin, and M. Worker et al. Treatment of disseminated ovarian cancer using nonviral interleukin-12 gene therapy delivered intraperitoneally J Gene Med 11 2009 718 728
8. K. Anwer, M.N. Barnes, J. Fewell, D.H. Lewis, and R.D. Alvarez Phase-I clinical trial of IL-12 plasmid/lipopolymer complexes for the treatment of recurrent ovarian cancer Gene Ther 17 2010 360 369
9. K. Anwer, F.J. Kelly, C. Chu, J.G. Fewell, D. Lewis, and R.D. Alvarez Phase I trial of a formulated IL-12 plasmid in combination with carboplatin and docetaxel chemotherapy in the treatment of platinum-sensitive recurrent ovarian cancer Gynecol Oncol 131 2013 169 173
10. M.W. Sill, L. Rubinstein, S. Litwin, and G. Yothers A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage phase II clinical trials Clin Trials 9 2012 385 395
11. R. Zagozdzon, J. Gołab, T. Stokłosa, A. Giermasz, D. Nowicka, and W. Feleszko et al. Effective chemo-immunotherapy of L1210 leukemia in vivo using interleukin-12 combined with doxorubicin but not with cyclophosphamide, paclitaxel or cisplatin Int J Cancer 77 1998 720 727
12. S. Zhu, M. Waguespack, S.A. Barker, and S. Li Doxorubicin directs the accumulation of interleukin-12 induced IFN gamma into tumors for enhancing STAT1 dependent antitumor effect Clin Cancer Res 13 2007 4252 4260
13. B.A. Teicher, G. Ara, D. Buxton, J. Leonard, and R.G. Schaub Optimal scheduling of interleukin 12 and chemotherapy in the murine MB-49 bladder carcinoma and B16 melanoma Clin Cancer Res 3 1997 1661 1667
14. I. Alagkiozidis, A. Facciabene, C. Carpenito, F. Benencia, Z. Jonak, and S. Adams et al. Increased immunogenicity of surviving tumor cells enables cooperation between liposomal doxorubicin and IL-18 J Transl Med 7 2009 104
15. K. Zarogoulidis, E. Ziogas, E. Boutsikou, P. Zarogoulidis, K. Darwiche, and T. Kontakiotis et al. Immunomodifiers in combination with conventional chemotherapy in small cell lung cancer: a phase II, randomized study Drug Des Devel Ther 7 2013 611 617
16. A.A. Tarhini, J. Cherian, S.J. Moschos, H.A. Tawbi, Y. Shuai, and W.E. Gooding et al. Safety and efficacy of combination immunotherapy with interferon alfa-2b and tremelimumab in patients with stage IV melanoma J Clin Oncol 30 2012 322 328
17. N. Casares, M.O. Pequignot, A. Tesniere, F. Ghiringhelli, S. Roux, and N. Chaput et al. Caspase-dependent immunogenicity of doxorubicin-induced tumor cell death J Exp Med 202 2005 1691 1701
18. P. Ujhazy, G. Zaleskis, and E. Mihich Doxorubicin induces specific immune functions and cytokine expression in peritoneal cells Cancer Immunol Immunother 52 2003 463 472
19. J.P. Machiels, R.T. Reilly, L.A. Emens, A.M. Ercolini, R.Y. Lei, and D. Weintraub et al. Cancer Res. 61 2001 3689 3697
20. P. Ujhazy, G. Zaleskis, E. Mihich, M.J. Ehrke, and E.S. Berleth Doxorubicin induces specific immune functions and cytokine expression in peritoneal cells Cancer Immunol Immunother. 52 2003 463 472
21. D. Alizadeh, M. Trad, N.T. Hanke, C.B. Larmonier, N. Janikashvili, and B. Bonnotte et al. Doxorubicin eliminates myeloid-derived suppressor cells and enhances the efficacy of adoptive T-cell transfer in breast cancer Cancer Res 74 2014 104 118