Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer

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