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

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