A Phase I Study of Active Immunotherapy With CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy that is refractory to standard therapy known to
have a survival benefit

- Stage IV disease

- Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following:

- Immunohistochemistry with at least 50% of the tumor with at least moderate
intensity of staining

- Peripheral blood CEA greater than 2.5 mg/dL

- Tumor known to be universally CEA positive (i.e., colon or rectal cancer)

- HLA-A201 positive

- Measurable disease*

- At least 1 unidimensionally measurable lesion at least 20 mm by conventional
techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic
confirmation is not required for measurable disease restricted to a solitary
lesion

- Received at least 1 prior standard chemotherapy regimen known to have a survival
benefit

- Previously resected brain metastases allowed provided CT scan or MRI was performed
within the past month and shows no metastasis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 6 months

Hematopoietic

- WBC at least 3,000/mm^3

- Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g.,
epoetin alfa] allowed)

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease)

- SGOT/SGPT less than 1.5 times upper limit of normal

- No hepatic disease that would preclude study participation

- No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and
hepatitis C serology

Renal

- Creatinine less than 2.5 mg/dL

- No urinary tract infection

Cardiovascular

- No New York Heart Association class III or IV heart disease

Immunologic

- No history of autoimmune disease, including any of the following:

- Inflammatory bowel disease

- Systemic lupus erythematosus

- Ankylosing spondylitis

- Scleroderma

- Multiple sclerosis

- No active acute or chronic infection

- HIV negative

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other serious chronic or acute illness that would preclude study participation

- No medical or psychological impediment that would preclude study compliance

- No other malignancy within the past 5 years except nonmelanoma skin cancer,
controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer

- No allergy to study vaccine components

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior immunotherapy

- No other concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- At least 6 weeks since prior steroid therapy (except steroids administered as
premedication for chemotherapy or contrast-enhanced studies)

- Concurrent hormonal therapy allowed for patients with breast cancer

- No concurrent steroid therapy

Radiotherapy

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- Recovered from prior therapy

- At least 4 weeks since prior investigational therapy

- At least 4 weeks since other prior therapy

- Any number of prior therapies are allowed

- Concurrent bisphosphonates allowed for bone metastases

- No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)

- No other concurrent experimental therapies