Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, lung metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma of the colon and rectum Must have undergone complete resection of hepatic or pulmonary metastases with curative intent No evidence of gross residual disease after surgery One or more resected and ablated lesions allowed provided all gross residual tumor was destroyed by ablation Repeated resections of hepatic metastatic disease or resections of extrahepatic metastases prior to resection of the hepatic metastases allowed provided the most recent hepatic metastatic resection included total disease resection and/or ablation Must have received at least 2 months of perioperative systemic chemotherapy (including preoperative and/or postoperative chemotherapy) that was completed at least 1 month ago PATIENT CHARACTERISTICS: Age At least 18 Performance status Karnofsky 70-100% Life expectancy At least 6 months Hematopoietic Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed) Hepatic Bilirubin ≤ 2.0 mg/dL Hepatitis B surface antigen negative Hepatitis C antibody negative No other serious chronic or acute hepatic disease Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance > 60 mL/min Cardiovascular No New York Heart Association class III or IV cardiac disease No other serious chronic or acute cardiac disease Pulmonary No asthma No chronic obstructive pulmonary disease No other serious chronic or acute pulmonary disease Immunologic No history of autoimmune disease, including, but not limited to, any of the following: Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma Multiple sclerosis No human immunodeficiency virus (HIV) infection by enzyme-linked immunosorbent assay (ELISA) and western blot Not immunocompromised (by disease or therapy) No allergy to eggs or any component of the study vaccine No history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination No allergy or untoward reaction to sargramostim (GM-CSF) No active acute or chronic infection, including urinary tract infection within the past 72 hours No inflammatory bowel conditions, including, but not limited to, the following: Active infectious enteritis Eosinophilic enteritis No acute, chronic, or exfoliative skin disorders, including any of the following: Extensive psoriasis Burns Impetigo Disseminated zoster Varicella zoster Severe acne Other open rashes or wounds Other Not pregnant or nursing Fertile patients must use effective contraception Able to avoid close contact or household contact for 3 weeks after each vaccination with the following individuals: Children under 5 years of age Pregnant or nursing women Individuals with prior or concurrent extensive eczema, other eczematoid skin disorders, or other acute or chronic skin conditions Immunosuppressed or immunodeficient individuals No medical or psychological condition that would preclude study compliance No extensive eczema No other serious chronic or acute illness that would preclude study participation No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled superficial bladder cancer, or previously treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent immunotherapy Chemotherapy See Disease Characteristics No concurrent chemotherapy Endocrine therapy More than 6 weeks since prior and no concurrent steroid therapy Radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Other No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)
Sites / Locations
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Duke Comprehensive Cancer Center
- Wake Forest University Baptist Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- Hollings Cancer Center at Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
PANVAC-V + PANVAC-F + DC
PANVAC-V + PANVAC-F + GM-CSF
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.