Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Breast Cancer, Colorectal Cancer, Gallbladder Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent gallbladder cancer, unresectable gallbladder cancer, thyroid gland medullary carcinoma, recurrent salivary gland cancer, stage III salivary gland cancer, stage IV salivary gland cancer, Paget disease of the breast with intraductal carcinoma, Paget disease of the breast with invasive ductal carcinoma, adult primary hepatocellular carcinoma, diffuse adenocarcinoma of the stomach, intestinal adenocarcinoma of the stomach, mixed adenocarcinoma of the stomach, adenocarcinoma of the colon, adenocarcinoma of the gallbladder, adenocarcinoma of the rectum, recurrent malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, male breast cancer, adenocarcinoma of the pancreas, cholangiocarcinoma of the gallbladder, salivary gland adenocarcinoma, ovarian endometrioid adenocarcinoma, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic malignancy expressing CEA Metastatic disease meeting one of the following criteria: Measurable or nonmeasurable History of metastases but no current evidence of disease, meeting one of the following criteria: Unresectable peritoneal or lymph node metastases that cannot be detected by imaging Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%) Must have completed treatment that rendered no evidence of disease within the past year CEA-expressing malignancy is defined by any of the following: Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining) CEA level in peripheral blood greater than 2.5 µg/L Tumor known to be universally CEA positive (e.g., colon and rectal cancer) Received prior therapy with possible survival benefit or refused such therapy Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Male or female Menopausal status Not specified Performance status Karnofsky 70-100% Life expectancy More than 6 months Hematopoietic WBC at least 3,000/mm^3 Absolute lymphocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 1.5 times upper limit of normal No active acute or chronic viral hepatitis Hepatitis B surface antigen negative Hepatitis C negative No other hepatic disease that would preclude study entry Renal Creatinine less than 2.5 mg/dL No active acute or chronic urinary tract infection Cardiovascular No New York Heart Association class III or IV heart disease Immunologic HIV negative No history of autoimmune disease, including, but not limited to, the following: Inflammatory bowel disease Systemic lupus erythematosus Rheumatoid arthritis Ankylosing spondylitis Scleroderma Multiple sclerosis No allergy to eggs or any component of study vaccine Other No active acute or chronic infection No concurrent serious acute or chronic illness that would preclude study entry No other medical or psychological impediment that would preclude study entry No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior biologic therapy and recovered No other concurrent immunotherapy Chemotherapy At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy At least 4 weeks since prior hormonal therapy and recovered At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies No concurrent steroids Radiotherapy Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery Not specified Other At least 4 weeks since any other prior therapy (including experimental therapy) and recovered No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)
Sites / Locations
- Duke Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
TRICOM-CEA(6D)
Subjects receiving TRICOM-CEA(6D)