A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA

Inclusion 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)