Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic colorectal adenocarcinoma

- No clinically active CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 6 months

Hematopoietic:

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

- Granulocyte count at least 1,500/mm^3

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

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- AST/ALT less than 3 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present)

- No hepatocellular dysfunction

- No cirrhosis

Renal:

- Creatinine less than 2.5 mg/dL

Cardiovascular:

- No uncontrolled coronary artery disease

- No symptomatic congestive heart failure

Pulmonary:

- No uncontrolled chronic obstructive lung disease

Gastrointestinal:

- No unsolved bowel obstruction or subobstruction

- No uncontrolled Crohn's disease

- No ulcerative colitis

- No concurrent chronic diarrhea

Immunologic:

- HIV negative

- No immunocompromised patients

- No diagnosis of altered immune function, including:

- Lupus erythematosus

- Sjogren's syndrome

- Scleroderma

- Myasthenia gravis

- Goodpasture's disease

- Addison's disease

- Hashimoto's thyroiditis

- Active Graves' disease

- No known allergy to egg products or neomycin

- No prior adverse reaction to tetanus toxoid-containing vaccines

Other:

- No significant comorbid medical function

- No uncontrolled infection

- No unstable diabetes mellitus

- No uncontrolled thyroid function abnormalities

- No other malignancy within the past 5 years except basal cell carcinoma or adequately
treated carcinoma in situ of the cervix

- No other medical illness or mental status that would preclude study participation

- No prior severe toxicity to adjuvant chemotherapy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior CEA-directed immunotherapy

- No other concurrent immunotherapy

Chemotherapy:

- At least 6 months since prior adjuvant chemotherapy

- No prior chemotherapy for metastatic disease

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent daily use of systemic steroids

- No concurrent nonsubstitutional hormonal therapy

Radiotherapy:

- No prior radiotherapy to more than 50% of all nodal groups

- No concurrent radiotherapy except for palliative purposes involving less than 20% of
bone marrow reserve

Surgery:

- No prior major organ allograft

- Recovered from prior surgery

Other:

- At least 28 days since prior investigational products

- No other concurrent investigational products