Biological Therapy in Treating Patients With Metastatic Cancer
Breast Cancer, Colorectal Cancer, Extrahepatic Bile Duct Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, inflammatory breast cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, thyroid gland medullary carcinoma, stage IV non-small cell lung cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, Paget disease of the breast with invasive ductal carcinoma, adult primary hepatocellular carcinoma, testicular yolk sac tumor, lung metastases, liver metastases, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, male breast cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma expressing carcinoembryonic antigen (CEA) that has failed conventional therapy Measurable or evaluable disease May include elevated CEA level No previously irradiated or known new CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 6 months Hematopoietic: WBC at least 3,000/mm3 Absolute lymphocyte count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 PT less than 1.25 times normal limit PTT less that 1.66 times normal limit Fibrinogen greater than 0.75 times normal limit Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No NYHA class III or IV Pulmonary: FEV1 greater than 70% of predicted FVC greater than 70% of predicted DLCO greater than 70% of predicted No asthma or chronic obstructive pulmonary disease Other: No active or chronic infection (including urinary tract infection) No viral hepatitis HIV negative No concurrent second malignancy other than nonmelanoma skin cancer or controlled superficial bladder cancer No hepatic disease No history of other autoimmune disease such as inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis PRIOR CONCURRENT THERAPY: Must have recovered from all acute toxic effects Biologic therapy: No concurrent biologic therapy At least 6 weeks since biologic therapy No concurrent immunotherapy No more than 1 prior biologic regimen Chemotherapy: No concurrent chemotherapy At least 6 weeks since chemotherapy No more than 1 prior chemotherapy regimen Endocrine therapy: At least 6 weeks since steroid therapy Radiotherapy: No concurrent radiotherapy At least 12 weeks since therapy including Sr 89 At least 6 weeks since other radiotherapy No prior cranial radiotherapy Surgery: Not specified Other: No concurrent immunosuppressives such as azathioprine or cyclosporine
Sites / Locations
- Duke Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
CEA RNA-pulsed DC cancer vaccine
carcinoembryonic antigen RNA-pulsed dendritic cells