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2002 JUL 3 - (NewsRx.com & NewsRx.net) -- Cell Genesys, Inc., (CEGE) announced the initiation of a phase II clinical trial of GVAX pancreatic cancer vaccine in patients with inoperable or metastatic pancreatic cancer. This trial was prompted by compelling results from an initial phase I clinical trial of GVAX pancreatic cancer vaccine which demonstrated prolonged, disease-free survival in three of eight patients treated at the higher dose levels.
The new phase II trial is in addition to a second ongoing phase II trial in patients with operable pancreatic cancer who receive GVAX pancreatic cancer vaccine in combination with pancreatic cancer surgery and standard adjuvant radiation and chemotherapy. The new trial is expected to enroll approximately 40 patients and will be conducted at medical centers across the United States.
The initial phase I trial of GVAX pancreatic cancer vaccine was conducted at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in 14 patients who received the vaccine following surgical resection of their tumor together with standard adjuvant radiation and chemotherapy. The results of this trial which were first reported in the Journal of Clinical Oncology in January 2001, revealed that three of eight patients who received the higher doses of vaccine were alive and disease-free at 38, 35, and 33 months after diagnosis, and this continues to be true at their most recent follow-up. In addition, the three patients with prolonged disease-free survival had biopsy-proven vaccine-induced antitumor immunity, a finding which was absent in the other five patients in the same treatment groups who had progressive pancreatic cancer. The significance of these findings was underscored by the fact that all three long term survivors were judged to be at high risk for recurrent cancer due to microscopic evidence of pancreatic tumor following surgery or metastatic tumor in pancreatic lymph nodes. As with other GVAX clinical trials, vaccine ...
Source: HighBeam Research, Phase II trial of GVAX cancer vaccine initiated.(Brief Article)