A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed locally advanced or metastatic colorectal cancer

- Metastatic disease must be radiologically proven

- HLA-A2-1 positive

- Locally advanced disease must have had prior resection or incomplete resection with
poor prognosis

- Locally advanced disease includes:

- Stage III or IV colon cancer (T4 or any T, N2-3, M0)

- Stage III or IV rectal cancer (T4 or T3, N1-3)

- Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or
surgery

- Absence of measurable disease but more than a 50% chance of recurrence

- Completely resected or locally advanced disease may have had conventional therapy
completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy
and/or radiotherapy) prior to study entry

- Metastatic disease patients must have bidimensionally measurable disease

- Bone lesions with well-demarcated borders allowed

- Lesions seen only on bone scan, pleural effusions, ascites, and changes in
carcinoembryonic antigen are not considered measurable disease

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Lymphocyte count at least 470/mm^3

- Granulocyte count at least 1,000/mm^3

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

Hepatic:

- Bilirubin no greater than 2.0 mg/dL*

- SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant
patients)*

- Albumin at least 3 g/dL

- No active viral hepatitis

- No evidence of chronic infection due to hepatitis C

- Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No history of cardiac failure, significant arrhythmias, or coronary artery disease
(metastatic disease patients only)

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

- No prior malignancy with a 50% chance of recurrence within 5 years except
nonmelanomatous skin cancer or carcinoma in situ of the cervix

- No medical or psychiatric condition that would preclude compliance

- No serious medical condition that would preclude apheresis

- No serious infection

- No uncontrolled thyroid disease (metastatic disease patients only)

- Patients with an allergy to eggs are allowed but are not vaccinated against influenza
during study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunologic therapy directed at the cellular immune system

Chemotherapy:

- See Disease Characteristics

- Prior chemotherapy for metastatic disease allowed

- At least 4 weeks since prior chemotherapy

- No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after
vaccinations

Endocrine therapy:

- At least 4 weeks since prior supraphysiologic steroid therapy

Radiotherapy:

- See Disease Characteristics

- Prior radiotherapy for metastatic disease allowed

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Prior surgery for metastatic disease allowed