Clinical trial NCT01703507 - References

Stage IV Melanoma — Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma

Citation(s)

•   Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr
  Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8.
•   Andrews DW
  Current neurosurgical management of brain metastases. Semin Oncol. 2008 Apr;35(2):100-7. doi: 10.1053/j.seminoncol.2007.12.003.
•   Aoyama H, Shirato H, Tago M, Nakagawa K, Toyoda T, Hatano K, Kenjyo M, Oya N, Hirota S, Shioura H, Kunieda E, Inomata T, Hayakawa K, Katoh N, Kobashi G
  Stereotactic radiosurgery plus whole-brain radiation therapy vs stereotactic radiosurgery alone for treatment of brain metastases: a randomized controlled trial. JAMA. 2006 Jun 7;295(21):2483-91. doi: 10.1001/jama.295.21.2483.
•   Bafaloukos D, Gogas H
  The treatment of brain metastases in melanoma patients. Cancer Treat Rev. 2004 Oct;30(6):515-20. doi: 10.1016/j.ctrv.2004.05.001.
•   Barth A, Wanek LA, Morton DL
  Prognostic factors in 1,521 melanoma patients with distant metastases. J Am Coll Surg. 1995 Sep;181(3):193-201.
•   Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group
  Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. doi: 10.1200/JCO.2006.06.0483. Epub 2006 Sep 11.
•   Borgelt B, Gelber R, Larson M, Hendrickson F, Griffin T, Roth R
  Ultra-rapid high dose irradiation schedules for the palliation of brain metastases: final results of the first two studies by the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 1981 Dec;7(12):1633-8. doi: 10.1016/0360-3016(81)90184-x. No abstract available.
•   Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM
  Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745-51. doi: 10.1200/JCO.1999.17.9.2745.
•   Chatani M, Matayoshi Y, Masaki N, Inoue T
  Radiation therapy for brain metastases from lung carcinoma. Prospective randomized trial according to the level of lactate dehydrogenase. Strahlenther Onkol. 1994 Mar;170(3):155-61.
•   CHU FC, HILARIS BB
  Value of radiation theray in the management of intracranial metastases. Cancer. 1961 May-Jun;14:577-81. doi: 10.1002/1097-0142(199005/06)14:33.0.co;2-f. No abstract available.
•   Clarke JW, Register S, McGregor JM, Grecula JC, Mayr NA, Wang JZ, Li K, Gupta N, Kendra KL, Olencki TE, Cavaliere R, Sarkar A, Lo SS
  Stereotactic radiosurgery with or without whole brain radiotherapy for patients with a single radioresistant brain metastasis. Am J Clin Oncol. 2010 Feb;33(1):70-4. doi: 10.1097/COC.0b013e31819ccc8c.
•   Clemente CG, Mihm MC Jr, Bufalino R, Zurrida S, Collini P, Cascinelli N
  Prognostic value of tumor infiltrating lymphocytes in the vertical growth phase of primary cutaneous melanoma. Cancer. 1996 Apr 1;77(7):1303-10. doi: 10.1002/(SICI)1097-0142(19960401)77:73.0.CO;2-5.
•   Davey P, Hoegler D, Ennis M, Smith J
  A phase III study of accelerated versus conventional hypofractionated whole brain irradiation in patients of good performance status with brain metastases not suitable for surgical excision. Radiother Oncol. 2008 Aug;88(2):173-6. doi: 10.1016/j.radonc.2008.05.020. Epub 2008 Jun 12.
•   DiLuna ML, King JT Jr, Knisely JP, Chiang VL
  Prognostic factors for survival after stereotactic radiosurgery vary with the number of cerebral metastases. Cancer. 2007 Jan 1;109(1):135-45. doi: 10.1002/cncr.22367.
•   Downey SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, Kammula US, Hughes MS, Allen TE, Levy CL, Yellin M, Nichol G, White DE, Steinberg SM, Rosenberg SA
  Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6681-8. doi: 10.1158/1078-0432.CCR-07-0187. Epub 2007 Nov 2.
•   Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J
  New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
•   Expert Panel on Radiation Oncology-Brain Metastases; Videtic GM, Gaspar LE, Aref AM, Germano IM, Goldsmith BJ, Imperato JP, Marcus KJ, McDermott MW, McDonald MW, Patchell RA, Robins HI, Rogers CL, Suh JH, Wolfson AH, Wippold FJ 2nd
  American College of Radiology appropriateness criteria on multiple brain metastases. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):961-5. doi: 10.1016/j.ijrobp.2009.07.1720. No abstract available.
•   Haie-Meder C, Pellae-Cosset B, Laplanche A, Lagrange JL, Tuchais C, Nogues C, Arriagada R
  Results of a randomized clinical trial comparing two radiation schedules in the palliative treatment of brain metastases. Radiother Oncol. 1993 Feb;26(2):111-6. doi: 10.1016/0167-8140(93)90091-l.
•   Hakansson A, Gustafsson B, Krysander L, Hakansson L
  Tumour-infiltrating lymphocytes in metastatic malignant melanoma and response to interferon alpha treatment. Br J Cancer. 1996 Sep;74(5):670-6. doi: 10.1038/bjc.1996.420.
•   Harwood AR, Simson WJ
  Radiation therapy of cerebral metastases: a randomized prospective clinical trial. Int J Radiat Oncol Biol Phys. 1977 Nov-Dec;2(11-12):1091-4. doi: 10.1016/0360-3016(77)90114-6. No abstract available.
•   Hodi FS, Butler M, Oble DA, Seiden MV, Haluska FG, Kruse A, Macrae S, Nelson M, Canning C, Lowy I, Korman A, Lautz D, Russell S, Jaklitsch MT, Ramaiya N, Chen TC, Neuberg D, Allison JP, Mihm MC, Dranoff G
  Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patients. Proc Natl Acad Sci U S A. 2008 Feb 26;105(8):3005-10. doi: 10.1073/pnas.0712237105. Epub 2008 Feb 19.
•   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, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ
  Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. Erratum In: N Engl J Med. 2010 Sep 23;363(13):1290.
•   Hodi FS, Oble DA, Drappatz J, Velazquez EF, Ramaiya N, Ramakrishna N, Day AL, Kruse A, Mac Rae S, Hoos A, Mihm M
  CTLA-4 blockade with ipilimumab induces significant clinical benefit in a female with melanoma metastases to the CNS. Nat Clin Pract Oncol. 2008 Sep;5(9):557-61. doi: 10.1038/ncponc1183. Epub 2008 Jul 29.
•   Jaber SH, Cowen EW, Haworth LR, Booher SL, Berman DM, Rosenberg SA, Hwang ST
  Skin reactions in a subset of patients with stage IV melanoma treated with anti-cytotoxic T-lymphocyte antigen 4 monoclonal antibody as a single agent. Arch Dermatol. 2006 Feb;142(2):166-72. doi: 10.1001/archderm.142.2.166.
•   Kaehler KC, Piel S, Livingstone E, Schilling B, Hauschild A, Schadendorf D
  Update on immunologic therapy with anti-CTLA-4 antibodies in melanoma: identification of clinical and biological response patterns, immune-related adverse events, and their management. Semin Oncol. 2010 Oct;37(5):485-98. doi: 10.1053/j.seminoncol.2010.09.003. Erratum In: Semin Oncol. 2012 Oct;39(5):625.
•   Khuntia D, Brown P, Li J, Mehta MP
  Whole-brain radiotherapy in the management of brain metastasis. J Clin Oncol. 2006 Mar 10;24(8):1295-304. doi: 10.1200/JCO.2005.04.6185.
•   Korn EL, Liu PY, Lee SJ, Chapman JA, Niedzwiecki D, Suman VJ, Moon J, Sondak VK, Atkins MB, Eisenhauer EA, Parulekar W, Markovic SN, Saxman S, Kirkwood JM
  Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008 Feb 1;26(4):527-34. doi: 10.1200/JCO.2007.12.7837.
•   Kurtz JM, Gelber R, Brady LW, Carella RJ, Cooper JS
  The palliation of brain metastases in a favorable patient population: a randomized clinical trial by the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 1981 Jul;7(7):891-5. doi: 10.1016/0360-3016(81)90005-5. No abstract available.
•   Lo SS, Clarke JW, Grecula JC, McGregor JM, Mayr NA, Cavaliere R, Kendra KL, Gupta N, Wang JZ, Sarkar A, Olencki TE
  Stereotactic radiosurgery alone for patients with 1-4 radioresistant brain metastases. Med Oncol. 2011 Dec;28 Suppl 1:S439-44. doi: 10.1007/s12032-010-9670-5. Epub 2010 Sep 3.
•   Manon R, O'Neill A, Knisely J, Werner-Wasik M, Lazarus HM, Wagner H, Gilbert M, Mehta M; Eastern Cooperative Oncology Group
  Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E 6397). J Clin Oncol. 2005 Dec 1;23(34):8870-6. doi: 10.1200/JCO.2005.01.8747.
•   Mathieu D, Kondziolka D, Cooper PB, Flickinger JC, Niranjan A, Agarwala S, Kirkwood J, Lunsford LD
  Gamma knife radiosurgery for malignant melanoma brain metastases. Clin Neurosurg. 2007;54:241-7. No abstract available.
•   Mehta MP, Tsao MN, Whelan TJ, Morris DE, Hayman JA, Flickinger JC, Mills M, Rogers CL, Souhami L
  The American Society for Therapeutic Radiology and Oncology (ASTRO) evidence-based review of the role of radiosurgery for brain metastases. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):37-46. doi: 10.1016/j.ijrobp.2005.05.023.
•   Meyners T, Heisterkamp C, Kueter JD, Veninga T, Stalpers LJ, Schild SE, Rades D
  Prognostic factors for outcomes after whole-brain irradiation of brain metastases from relatively radioresistant tumors: a retrospective analysis. BMC Cancer. 2010 Oct 26;10:582. doi: 10.1186/1471-2407-10-582.
•   Middleton MR, Lorigan P, Owen J, Ashcroft L, Lee SM, Harper P, Thatcher N
  A randomized phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma. Br J Cancer. 2000 Mar;82(6):1158-62. doi: 10.1054/bjoc.1999.1056.
•   Mihm MC Jr, Clemente CG, Cascinelli N
  Tumor infiltrating lymphocytes in lymph node melanoma metastases: a histopathologic prognostic indicator and an expression of local immune response. Lab Invest. 1996 Jan;74(1):43-7.
•   Morse MA
  Technology evaluation: ipilimumab, Medarex/Bristol-Myers Squibb. Curr Opin Mol Ther. 2005 Dec;7(6):588-97.
•   Moschos SJ, Edington HD, Land SR, Rao UN, Jukic D, Shipe-Spotloe J, Kirkwood JM
  Neoadjuvant treatment of regional stage IIIB melanoma with high-dose interferon alfa-2b induces objective tumor regression in association with modulation of tumor infiltrating host cellular immune responses. J Clin Oncol. 2006 Jul 1;24(19):3164-71. doi: 10.1200/JCO.2005.05.2498.
•   Murray KJ, Scott C, Greenberg HM, Emami B, Seider M, Vora NL, Olson C, Whitton A, Movsas B, Curran W
  A randomized phase III study of accelerated hyperfractionation versus standard in patients with unresected brain metastases: a report of the Radiation Therapy Oncology Group (RTOG) 9104. Int J Radiat Oncol Biol Phys. 1997 Oct 1;39(3):571-4. doi: 10.1016/s0360-3016(97)00341-6.
•   Nagorsen D, Scheibenbogen C, Marincola FM, Letsch A, Keilholz U
  Natural T cell immunity against cancer. Clin Cancer Res. 2003 Oct 1;9(12):4296-303.
•   Order SE, Hellman S, Von Essen CF, Kligerman MM
  Improvement in quality of survival following whole-brain irradiation for brain metastasis. Radiology. 1968 Jul;91(1):149-53. doi: 10.1148/91.1.149. No abstract available.
•   Patchell RA, Regine WF
  The rationale for adjuvant whole brain radiation therapy with radiosurgery in the treatment of single brain metastases. Technol Cancer Res Treat. 2003 Apr;2(2):111-5. doi: 10.1177/153303460300200206.
•   Patchell RA, Tibbs PA, Regine WF, Dempsey RJ, Mohiuddin M, Kryscio RJ, Markesbery WR, Foon KA, Young B
  Postoperative radiotherapy in the treatment of single metastases to the brain: a randomized trial. JAMA. 1998 Nov 4;280(17):1485-9. doi: 10.1001/jama.280.17.1485.
•   Patchell RA, Tibbs PA, Walsh JW, Dempsey RJ, Maruyama Y, Kryscio RJ, Markesbery WR, Macdonald JS, Young B
  A randomized trial of surgery in the treatment of single metastases to the brain. N Engl J Med. 1990 Feb 22;322(8):494-500. doi: 10.1056/NEJM199002223220802.
•   Peggs KS, Quezada SA, Korman AJ, Allison JP
  Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr Opin Immunol. 2006 Apr;18(2):206-13. doi: 10.1016/j.coi.2006.01.011. Epub 2006 Feb 7.
•   Pilones KA, Kawashima N, Yang AM, Babb JS, Formenti SC, Demaria S
  Invariant natural killer T cells regulate breast cancer response to radiation and CTLA-4 blockade. Clin Cancer Res. 2009 Jan 15;15(2):597-606. doi: 10.1158/1078-0432.CCR-08-1277.
•   Pirzkall A, Debus J, Lohr F, Fuss M, Rhein B, Engenhart-Cabillic R, Wannenmacher M
  Radiosurgery alone or in combination with whole-brain radiotherapy for brain metastases. J Clin Oncol. 1998 Nov;16(11):3563-9. doi: 10.1200/JCO.1998.16.11.3563.
•   Powell JW, Chung CT, Shah HR, Canute GW, Hodge CJ, Bassano DA, Liu L, Mitchell L, Hahn SS
  Gamma Knife surgery in the management of radioresistant brain metastases in high-risk patients with melanoma, renal cell carcinoma, and sarcoma. J Neurosurg. 2008 Dec;109 Suppl:122-8. doi: 10.3171/JNS/2008/109/12/S19.
•   Read S, Malmstrom V, Powrie F
  Cytotoxic T lymphocyte-associated antigen 4 plays an essential role in the function of CD25(+)CD4(+) regulatory cells that control intestinal inflammation. J Exp Med. 2000 Jul 17;192(2):295-302. doi: 10.1084/jem.192.2.295.
•   Robert C, Ghiringhelli F
  What is the role of cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma? Oncologist. 2009 Aug;14(8):848-61. doi: 10.1634/theoncologist.2009-0028. Epub 2009 Aug 1.
•   Robinson MR, Chan CC, Yang JC, Rubin BI, Gracia GJ, Sen HN, Csaky KG, Rosenberg SA
  Cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma: a new cause of uveitis. J Immunother. 2004 Nov-Dec;27(6):478-9. doi: 10.1097/00002371-200411000-00008.
•   Sampson JH, Carter JH Jr, Friedman AH, Seigler HF
  Demographics, prognosis, and therapy in 702 patients with brain metastases from malignant melanoma. J Neurosurg. 1998 Jan;88(1):11-20. doi: 10.3171/jns.1998.88.1.0011.
•   Schartz NE, Farges C, Madelaine I, Bruzzoni H, Calvo F, Hoos A, Lebbe C
  Complete regression of a previously untreated melanoma brain metastasis with ipilimumab. Melanoma Res. 2010 Jun;20(3):247-50. doi: 10.1097/CMR.0b013e3283364a37.
•   Shaw E, Scott C, Souhami L, Dinapoli R, Kline R, Loeffler J, Farnan N
  Single dose radiosurgical treatment of recurrent previously irradiated primary brain tumors and brain metastases: final report of RTOG protocol 90-05. Int J Radiat Oncol Biol Phys. 2000 May 1;47(2):291-8. doi: 10.1016/s0360-3016(99)00507-6.
•   Sheehan JP, Sun MH, Kondziolka D, Flickinger J, Lunsford LD
  Radiosurgery in patients with renal cell carcinoma metastasis to the brain: long-term outcomes and prognostic factors influencing survival and local tumor control. J Neurosurg. 2003 Feb;98(2):342-9. doi: 10.3171/jns.2003.98.2.0342.
•   Suh JH, Videtic GM, Aref AM, Germano I, Goldsmith BJ, Imperato JP, Marcus KJ, McDermott MW, McDonald MW, Patchell RA, Robins HI, Rogers CL, Wolfson AH, Wippold FJ 2nd, Gaspar LE
  ACR Appropriateness Criteria: single brain metastasis. Curr Probl Cancer. 2010 May-Jun;34(3):162-74. doi: 10.1016/j.currproblcancer.2010.04.003.
•   Tarhini AA, Iqbal F
  CTLA-4 blockade: therapeutic potential in cancer treatments. Onco Targets Ther. 2010 Jun 24;3:15-25. doi: 10.2147/ott.s4833.
•   Thomas SS, Dunbar EM
  Modern multidisciplinary management of brain metastases. Curr Oncol Rep. 2010 Jan;12(1):34-40. doi: 10.1007/s11912-009-0073-8.
•   van Elsas A, Hurwitz AA, Allison JP
  Combination immunotherapy of B16 melanoma using anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and granulocyte/macrophage colony-stimulating factor (GM-CSF)-producing vaccines induces rejection of subcutaneous and metastatic tumors accompanied by autoimmune depigmentation. J Exp Med. 1999 Aug 2;190(3):355-66. doi: 10.1084/jem.190.3.355.
•   Weber JS, O'Day S, Urba W, Powderly J, Nichol G, Yellin M, Snively J, Hersh E
  Phase I/II study of ipilimumab for patients with metastatic melanoma. J Clin Oncol. 2008 Dec 20;26(36):5950-6. doi: 10.1200/JCO.2008.16.1927. Epub 2008 Nov 17.

Phase I Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma Patients With Brain Metastases

Details for clinical trial NCT01703507