Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA (6D)/TRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas

Title

Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA (6D)/TRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas

Lead sponsor

National Cancer Institute (NCI)

Phase

Phase 1

Overall status

Completed

Start date

November 30, 2001

Completion date

-Not reported

Enrollment

48 (actual)

Sites

1

adenocarcinoma of the colon, adenocarcinoma of the gallbladder, adenocarcinoma of the pancreas, adenocarcinoma of the rectum, adult primary hepatocellular carcinoma, advanced adult primary liver cancer, cholangiocarcinoma of the gallbladder, diffuse adenocarcinoma of the stomach, intestinal adenocarcinoma of the stomach, male breast cancer, mixed adenocarcinoma of the stomach, ovarian endometrioid adenocarcinoma, paget disease of the breast with intraductal carcinoma, paget disease of the breast with invasive ductal carcinoma, recurrent adult primary liver cancer, recurrent breast cancer, recurrent colon cancer, recurrent gallbladder cancer, recurrent gastric cancer, recurrent malignant testicular germ cell tumor, recurrent pancreatic cancer, recurrent rectal cancer, recurrent salivary gland cancer, salivary gland adenocarcinoma, stage ii malignant testicular germ cell tumor, stage ii pancreatic cancer, stage iii colon cancer, stage iii gastric cancer, stage iii malignant testicular germ cell tumor, stage iii pancreatic cancer, stage iii rectal cancer, stage iii salivary gland cancer, stage iiia breast cancer, stage iiib breast cancer, stage iv breast cancer, stage iv colon cancer, stage iv gastric cancer, stage iv pancreatic cancer, stage iv rectal cancer, stage iv salivary gland cancer, thyroid gland medullary carcinoma, unresectable gallbladder cancer