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A multipeptide vaccine plus toll-like receptor agonists LPS or polyICLC in combination with incomplete Freund's adjuvant in melanoma patients.

Melssen MM, Petroni GR, Chianese-Bullock KA, Wages NA, Grosh WW, Varhegyi N, Smolkin ME, Smith KT, Galeassi NV, Deacon DH, Gaughan EM, Slingluff CL Jr.

J Immunother Cancer. 2019 Jun 27;7(1):163. doi: 10.1186/s40425-019-0625-x.


The Role of Early-Phase Design-Response.

Conaway MR, Petroni GR.

Clin Cancer Res. 2019 May 15;25(10):3191. doi: 10.1158/1078-0432.CCR-19-0618. No abstract available.


A window-of-opportunity clinical trial of dasatinib in women with newly diagnosed endometrial cancer.

Duska LR, Petroni GR, Lothamer H, Faust W Jr, Beumer JH, Christner SM, Mills AM, Fracasso PM, Parsons SJ.

Cancer Chemother Pharmacol. 2019 Mar;83(3):473-482. doi: 10.1007/s00280-018-3749-7. Epub 2018 Dec 8.


The Impact of Early-Phase Trial Design in the Drug Development Process.

Conaway MR, Petroni GR.

Clin Cancer Res. 2019 Jan 15;25(2):819-827. doi: 10.1158/1078-0432.CCR-18-0203. Epub 2018 Oct 16.


A web tool for designing and conducting phase I trials using the continual reassessment method.

Wages NA, Petroni GR.

BMC Cancer. 2018 Feb 5;18(1):133. doi: 10.1186/s12885-018-4038-x.


A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus poly-ICLC in early stage breast cancer.

Dillon PM, Petroni GR, Smolkin ME, Brenin DR, Chianese-Bullock KA, Smith KT, Olson WC, Fanous IS, Nail CJ, Brenin CM, Hall EH, Slingluff CL Jr.

J Immunother Cancer. 2017 Nov 21;5(1):92. doi: 10.1186/s40425-017-0295-5.


Implementation of a Model-Based Design in a Phase Ib Study of Combined Targeted Agents.

Wages NA, Portell CA, Williams ME, Conaway MR, Petroni GR.

Clin Cancer Res. 2017 Dec 1;23(23):7158-7164. doi: 10.1158/1078-0432.CCR-17-1069. Epub 2017 Jul 21.


A Phase II Study of Dovitinib in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma.

Dillon PM, Petroni GR, Horton BJ, Moskaluk CA, Fracasso PM, Douvas MG, Varhegyi N, Zaja-Milatovic S, Thomas CY.

Clin Cancer Res. 2017 Aug 1;23(15):4138-4145. doi: 10.1158/1078-0432.CCR-16-2942. Epub 2017 Apr 4.


Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies.

Wages NA, Slingluff CL Jr, Petroni GR.

Ann Oncol. 2017 Apr 1;28(4):696-701. doi: 10.1093/annonc/mdw681.


Topical treatment of melanoma metastases with imiquimod, plus administration of a cancer vaccine, promotes immune signatures in the metastases.

Mauldin IS, Wages NA, Stowman AM, Wang E, Olson WC, Deacon DH, Smith KT, Galeassi N, Teague JE, Smolkin ME, Chianese-Bullock KA, Clark RA, Petroni GR, Marincola FM, Mullins DW, Slingluff CL Jr.

Cancer Immunol Immunother. 2016 Oct;65(10):1201-12. doi: 10.1007/s00262-016-1880-z. Epub 2016 Aug 13.


Intratumoral interferon-gamma increases chemokine production but fails to increase T cell infiltration of human melanoma metastases.

Mauldin IS, Wages NA, Stowman AM, Wang E, Smolkin ME, Olson WC, Deacon DH, Smith KT, Galeassi NV, Chianese-Bullock KA, Dengel LT, Marincola FM, Petroni GR, Mullins DW, Slingluff CL Jr.

Cancer Immunol Immunother. 2016 Oct;65(10):1189-99. doi: 10.1007/s00262-016-1881-y. Epub 2016 Aug 13.


Implementation of adaptive methods in early-phase clinical trials.

Petroni GR, Wages NA, Paux G, Dubois F.

Stat Med. 2017 Jan 30;36(2):215-224. doi: 10.1002/sim.6910. Epub 2016 Feb 29. Review.


A randomized pilot trial testing the safety and immunologic effects of a MAGE-A3 protein plus AS15 immunostimulant administered into muscle or into dermal/subcutaneous sites.

Slingluff CL Jr, Petroni GR, Olson WC, Smolkin ME, Chianese-Bullock KA, Mauldin IS, Smith KT, Deacon DH, Varhegyi NE, Donnelly SB, Reed CM, Scott K, Galeassi NV, Grosh WW.

Cancer Immunol Immunother. 2016 Jan;65(1):25-36. doi: 10.1007/s00262-015-1770-9. Epub 2015 Nov 18.


A Phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation therapy trial.

Wages NA, Read PW, Petroni GR.

Pharm Stat. 2015 Jul-Aug;14(4):302-10. doi: 10.1002/pst.1686. Epub 2015 May 11.


Recent developments in the implementation of novel designs for early-phase combination studies.

Wages NA, Conaway MR, Slingluff CL Jr, Williams ME, Portell CA, Hwu P, Petroni GR.

Ann Oncol. 2015 May;26(5):1036-7. doi: 10.1093/annonc/mdv075. Epub 2015 Feb 19. No abstract available.


A Phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma.

Wages NA, Slingluff CL Jr, Petroni GR.

Contemp Clin Trials. 2015 Mar;41:172-9. doi: 10.1016/j.cct.2015.01.016. Epub 2015 Jan 29.


Total body photography for skin cancer screening.

Dengel LT, Petroni GR, Judge J, Chen D, Acton ST, Schroen AT, Slingluff CL Jr.

Int J Dermatol. 2015 Nov;54(11):1250-4. doi: 10.1111/ijd.12593. Epub 2014 Dec 16.


A melanoma helper peptide vaccine increases Th1 cytokine production by leukocytes in peripheral blood and immunized lymph nodes.

Dillon PM, Olson WC, Czarkowski A, Petroni GR, Smolkin M, Grosh WW, Chianese-Bullock KA, Deacon DH, Slingluff CL Jr.

J Immunother Cancer. 2014 Jul 15;2:23. doi: 10.1186/2051-1426-2-23. eCollection 2014.


Inflammatory adverse events are associated with disease-free survival after vaccine therapy among patients with melanoma.

Hu Y, Smolkin ME, White EJ, Petroni GR, Neese PY, Slingluff CL Jr.

Ann Surg Oncol. 2014 Nov;21(12):3978-84. doi: 10.1245/s10434-014-3794-3. Epub 2014 May 20.


Immunologic hierarchy, class II MHC promiscuity, and epitope spreading of a melanoma helper peptide vaccine.

Hu Y, Petroni GR, Olson WC, Czarkowski A, Smolkin ME, Grosh WW, Chianese-Bullock KA, Slingluff CL Jr.

Cancer Immunol Immunother. 2014 Aug;63(8):779-86. doi: 10.1007/s00262-014-1551-x. Epub 2014 Apr 23. Erratum in: Cancer Immunol Immunother. 2014 Oct;63(10):1113.


Factors related to decision making and substance use in adolescent survivors of childhood cancer: a presenting clinical profile.

Hollen PJ, Tyc VL, Shannon SV, Donnangelo SF, Hobbie WL, Hudson MM, O'Laughlen MC, Smolkin ME, Petroni GR.

J Cancer Surviv. 2013 Sep;7(3):500-10. doi: 10.1007/s11764-013-0287-5. Epub 2013 May 28.


Activation, dysfunction and retention of T cells in vaccine sites after injection of incomplete Freund's adjuvant, with or without peptide.

Salerno EP, Shea SM, Olson WC, Petroni GR, Smolkin ME, McSkimming C, Chianese-Bullock KA, Slingluff CL Jr.

Cancer Immunol Immunother. 2013 Jul;62(7):1149-59. doi: 10.1007/s00262-013-1435-5. Epub 2013 May 9.


Clinical activity and safety of combination therapy with temsirolimus and bevacizumab for advanced melanoma: a phase II trial (CTEP 7190/Mel47).

Slingluff CL Jr, Petroni GR, Molhoek KR, Brautigan DL, Chianese-Bullock KA, Shada AL, Smolkin ME, Olson WC, Gaucher A, Chase CM, Grosh WW, Weiss GR, Wagenseller AG, Olszanski AJ, Martin L, Shea SM, Erdag G, Ram P, Gershenwald JE, Weber MJ.

Clin Cancer Res. 2013 Jul 1;19(13):3611-20. doi: 10.1158/1078-0432.CCR-12-3919. Epub 2013 Apr 25.


A substance use decision aid for medically at-risk adolescents: results of a randomized controlled trial for cancer-surviving adolescents.

Hollen PJ, Tyc VL, Donnangelo SF, Shannon SV, O'Laughlen MC, Hinton I, Smolkin ME, Petroni GR.

Cancer Nurs. 2013 Sep-Oct;36(5):355-67. doi: 10.1097/NCC.0b013e31827910ba.


A phase II study of UCN-01 in combination with irinotecan in patients with metastatic triple negative breast cancer.

Ma CX, Ellis MJ, Petroni GR, Guo Z, Cai SR, Ryan CE, Craig Lockhart A, Naughton MJ, Pluard TJ, Brenin CM, Picus J, Creekmore AN, Mwandoro T, Yarde ER, Reed J, Ebbert M, Bernard PS, Watson M, Doyle LA, Dancey J, Piwnica-Worms H, Fracasso PM.

Breast Cancer Res Treat. 2013 Jan;137(2):483-92. doi: 10.1007/s10549-012-2378-9. Epub 2012 Dec 15.


Phase I trial of induction histone deacetylase and proteasome inhibition followed by surgery in non-small-cell lung cancer.

Jones DR, Moskaluk CA, Gillenwater HH, Petroni GR, Burks SG, Philips J, Rehm PK, Olazagasti J, Kozower BD, Bao Y.

J Thorac Oncol. 2012 Nov;7(11):1683-90. doi: 10.1097/JTO.0b013e318267928d.


A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

Hollen PJ, Gralla RJ, Jones RA, Thomas CY, Brenin DR, Weiss GR, Schroen AT, Petroni GR.

Support Care Cancer. 2013 Mar;21(3):889-99. doi: 10.1007/s00520-012-1603-8. Epub 2012 Oct 11.


Infrared thermography of cutaneous melanoma metastases.

Shada AL, Dengel LT, Petroni GR, Smolkin ME, Acton S, Slingluff CL Jr.

J Surg Res. 2013 Jun 1;182(1):e9-e14. doi: 10.1016/j.jss.2012.09.022. Epub 2012 Sep 27.


The vaccine-site microenvironment induced by injection of incomplete Freund's adjuvant, with or without melanoma peptides.

Harris RC, Chianese-Bullock KA, Petroni GR, Schaefer JT, Brill LB 2nd, Molhoek KR, Deacon DH, Patterson JW, Slingluff CL Jr.

J Immunother. 2012 Jan;35(1):78-88. doi: 10.1097/CJI.0b013e31823731a4.


Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups.

Schroen AT, Petroni GR, Wang H, Thielen MJ, Gray R, Benedetti J, Wang XF, Sargent DJ, Wickerham DL, Cronin W, Djulbegovic B, Slingluff CL Jr.

Clin Cancer Res. 2012 Jan 1;18(1):256-62. doi: 10.1158/1078-0432.CCR-11-1633. Epub 2011 Oct 5.


Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials.

Schroen AT, Petroni GR, Wang H, Thielen MJ, Sargent D, Benedetti JK, Cronin WM, Wickerham DL, Wang XF, Gray R, Cohn WF, Slingluff CL, Djulbegovic B.

Clin Trials. 2011 Oct;8(5):591-600. doi: 10.1177/1740774511419683. Epub 2011 Aug 30.


Randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine.

Slingluff CL Jr, Petroni GR, Chianese-Bullock KA, Smolkin ME, Ross MI, Haas NB, von Mehren M, Grosh WW.

J Clin Oncol. 2011 Jul 20;29(21):2924-32. doi: 10.1200/JCO.2010.33.8053. Epub 2011 Jun 20.


Intraoperative imaging guidance for sentinel node biopsy in melanoma using a mobile gamma camera.

Dengel LT, More MJ, Judy PG, Petroni GR, Smolkin ME, Rehm PK, Majewski S, Williams MB, Slingluff CL Jr.

Ann Surg. 2011 Apr;253(4):774-8. doi: 10.1097/SLA.0b013e3181f9b709.


Dynamic changes in cellular infiltrates with repeated cutaneous vaccination: a histologic and immunophenotypic analysis.

Schaefer JT, Patterson JW, Deacon DH, Smolkin ME, Petroni GR, Jackson EM, Slingluff CL Jr.

J Transl Med. 2010 Aug 20;8:79. doi: 10.1186/1479-5876-8-79.


Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

Schroen AT, Petroni GR, Wang H, Gray R, Wang XF, Cronin W, Sargent DJ, Benedetti J, Wickerham DL, Djulbegovic B, Slingluff CL Jr.

Clin Trials. 2010 Aug;7(4):312-21. doi: 10.1177/1740774510374973. Epub 2010 Jul 1.


Immunogenicity for CD8+ and CD4+ T cells of 2 formulations of an incomplete freund's adjuvant for multipeptide melanoma vaccines.

Slingluff CL, Petroni GR, Smolkin ME, Chianese-Bullock KA, Smith K, Murphy C, Galeassi N, Neese PY, Grosh WW, Nail CJ, Ross M, von Mehren M, Haas N, Boisvert ME, Kirkwood JM.

J Immunother. 2010 Jul-Aug;33(6):630-8. doi: 10.1097/CJI.0b013e3181e311ac.


Effect of granulocyte/macrophage colony-stimulating factor on circulating CD8+ and CD4+ T-cell responses to a multipeptide melanoma vaccine: outcome of a multicenter randomized trial.

Slingluff CL Jr, Petroni GR, Olson WC, Smolkin ME, Ross MI, Haas NB, Grosh WW, Boisvert ME, Kirkwood JM, Chianese-Bullock KA.

Clin Cancer Res. 2009 Nov 15;15(22):7036-44. doi: 10.1158/1078-0432.CCR-09-1544. Epub 2009 Nov 10.


Phase I trial of intrapleural docetaxel administered through an implantable catheter in subjects with a malignant pleural effusion.

Jones DR, Taylor MD, Petroni GR, Shu J, Burks SG, Daniel TM, Gillenwater HH.

J Thorac Oncol. 2010 Jan;5(1):75-81. doi: 10.1097/JTO.0b013e3181c07ddc.


Breast cancer metastasis suppressor 1 (BRMS1) suppresses metastasis and correlates with improved patient survival in non-small cell lung cancer.

Smith PW, Liu Y, Siefert SA, Moskaluk CA, Petroni GR, Jones DR.

Cancer Lett. 2009 Apr 18;276(2):196-203. doi: 10.1016/j.canlet.2008.11.024. Epub 2008 Dec 25.


Evaluation of the sentinel immunized node for immune monitoring of cancer vaccines.

Slingluff CL Jr, Yamshchikov GV, Hogan KT, Hibbitts SC, Petroni GR, Bissonette EA, Patterson JW, Neese PY, Grosh WW, Chianese-Bullock KA, Czarkowski A, Rehm PK, Parekh J.

Ann Surg Oncol. 2008 Dec;15(12):3538-49. doi: 10.1245/s10434-008-0046-4. Epub 2008 Oct 16.


Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and melanocytic differentiation antigens.

Slingluff CL Jr, Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, Chianese-Bullock KA, Neese PY, Deacon DH, Nail C, Merrill P, Fink R, Patterson JW, Rehm PK.

J Clin Oncol. 2008 Oct 20;26(30):4973-80. doi: 10.1200/JCO.2008.17.3161. Epub 2008 Sep 22.


A multipeptide vaccine is safe and elicits T-cell responses in participants with advanced stage ovarian cancer.

Chianese-Bullock KA, Irvin WP Jr, Petroni GR, Murphy C, Smolkin M, Olson WC, Coleman E, Boerner SA, Nail CJ, Neese PY, Yuan A, Hogan KT, Slingluff CL Jr.

J Immunother. 2008 May;31(4):420-30. doi: 10.1097/CJI.0b013e31816dad10.


Immunologic and clinical outcomes of a randomized phase II trial of two multipeptide vaccines for melanoma in the adjuvant setting.

Slingluff CL Jr, Petroni GR, Chianese-Bullock KA, Smolkin ME, Hibbitts S, Murphy C, Johansen N, Grosh WW, Yamshchikov GV, Neese PY, Patterson JW, Fink R, Rehm PK.

Clin Cancer Res. 2007 Nov 1;13(21):6386-95.


Accuracy of assigned BI-RADS breast density category definitions.

Nicholson BT, LoRusso AP, Smolkin M, Bovbjerg VE, Petroni GR, Harvey JA.

Acad Radiol. 2006 Sep;13(9):1143-9.


Autoimmune toxicities associated with the administration of antitumor vaccines and low-dose interleukin-2.

Chianese-Bullock KA, Woodson EM, Tao H, Boerner SA, Smolkin M, Grosh WW, Neese PY, Merrill P, Petroni GR, Slingluff CL Jr.

J Immunother. 2005 Jul-Aug;28(4):412-9.


Altered expression of TFF-1 and CES-2 in Barrett's Esophagus and associated adenocarcinomas.

Fox CA, Sapinoso LM, Zhang H, Zhang W, McLeod HL, Petroni GR, Mullick T, Moskaluk CA, Frierson HF, Hampton GM, Powell SM.

Neoplasia. 2005 Apr;7(4):407-16.


Low-dose IL-2 induces cytokine cascade, eosinophilia, and a transient Th2 shift in melanoma patients.

Cragun WC, Yamshchikov GV, Bissonette EA, Smolkin ME, Eastham S, Petroni GR, Schrecengost RS, Woodson EM, Slingluff CL Jr.

Cancer Immunol Immunother. 2005 Nov;54(11):1095-105. Epub 2005 May 12.


MAGE-A1-, MAGE-A10-, and gp100-derived peptides are immunogenic when combined with granulocyte-macrophage colony-stimulating factor and montanide ISA-51 adjuvant and administered as part of a multipeptide vaccine for melanoma.

Chianese-Bullock KA, Pressley J, Garbee C, Hibbitts S, Murphy C, Yamshchikov G, Petroni GR, Bissonette EA, Neese PY, Grosh WW, Merrill P, Fink R, Woodson EM, Wiernasz CJ, Patterson JW, Slingluff CL Jr.

J Immunol. 2005 Mar 1;174(5):3080-6.

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