Bibliography
- HOOS A, PARMIANI G, HEGE K et al.: A clinical development paradigm for cancer vaccines and related biologics. J. Immunother. (2007) 30:1-15.
- MICHAELIS LC, RATAIN MJ: Measuring response in a post-RECIST world: from black and white to shades of grey. Nat. Rev. Cancer (2006) 6:409-414.
- ROSENBERG SA, YANG JC, RESTIFO N: Cancer immunotherapy: moving beyond current vaccines. Nat. Med. (2004) 10:909-915.
- MACKIEWICZ A, GORNY A, LACIAK M et al.: Gene therapy of human melanoma. Immunization of patients with autologous tumor cells admixed with allogeneic melanoma cells secreting IL-6 and soluble interleukin 6 receptor. Hum. Gene Ther. (1995) 6:805-811.
- NAWROCKI S, MURAWA P, MALICKI J et al.: Genetically modified tumour vaccines (GMTV) in melanoma clinical trials. Immunol. Lett. (2000) 15:81-86.
- BOON T, COULIE PG, VAN DEN EYNDE BJ et al.: Human T cell responses against melanoma. Ann. Rev. Immunol. (2006) 24:175-208.
- THERASSE P, ARBUCK SG, EISENHAUER EA et al.: New guidelines to evaluate the response to treatment in solid tumors. J. Natl. Cancer Inst. (2000) 92:205-216.
- VON HOFF DD: There are no bad anticancer agents, only bad clinical trial designs – twenty-first Richard and Hinda Rosenthal Foundation Award Lecture. Clin. Cancer Res. (1998) 4:1079-1089.
- NAGORSEN D, THIEL E: Clinical and immunologic responses to active specific cancer vaccines in human colorectal cancer. Clin. Cancer Res. (2006) 12:3064-3069.
- SEYMOUR L: The design of clinical trials for new molecularly targeted compounds: progress and new initiatives. Curr. Pharm. Des. (2002) 8:2279-2284.
- SCHILSKY RL: End points in cancer clinical trials and drug approval process. Clin. Cancer Res. (2002) 8:935-938.
- SIMON RM, STEINBERG SM, HAMILTON M et al.: Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J. Clin. Oncol. (2001) 19:1848-1854.
- SIMON RM: Clinical trial designs for therapeutic cancer vaccines. Cancer Treat. Res. (2005) 123:339-350.
- RUBINSTEIN LV, KORN EL, FREIDLIN B et al.: Design issues of randomized Phase II trials and a proposal for Phase II screening trials. J. Clin. Oncol. (2005) 23:7199-7206.