Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer

Inclusion Criteria:

• Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks

  • Advanced or metastatic disease
  • Recurrent or unresectable disease
  • Microscopic metastatic disease confirmed by surgical exploration allowed
• CEA expression by immunohistochemistry
• Circulating CEA greater than 5 ng/mL

• HLA phenotyping required

  • HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation

• No clinically symptomatic brain metastases

  • Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible

• Hormone receptor status:

  • Not specified
• Male or female
• Performance status - ECOG 0-1
• WBC at least 3,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• AST and ALT less than 3 times ULN
• PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated)
• Creatinine less than 1.5 mg/dL
• Creatinine clearance greater than 60 mL/min
• Proteinuria or hematuria less than +2 on urinalysis*
• Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1
• No frequent vomiting or severe anorexia
• No more than 10% weight loss within the past 3 months
• No inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
• No uncontrolled seizure disorders
• No encephalitis
• No multiple sclerosis
• No allergy to eggs
• No HIV-associated opportunistic infection

• No autoimmune diseases, including the following:

  • Systemic lupus erythematosus
  • Sjögren's syndrome
  • Scleroderma
  • Myasthenia gravis
  • Goodpasture syndrome
  • Addison's disease
  • Hashimoto's thyroiditis
  • Graves' disease
• Antinuclear antibody positive status allowed if no evidence of an autoimmune disease

• No direct contact of vaccination site with the following persons for at least 72 hours after each vaccination:

  • Children under 1 year of age
  • Pregnant women
  • Individuals with eczema or other open skin condition
  • Immunocompromised individuals
• No other concurrent serious medical illness that would preclude study entry
• No other malignancy within the past 2 years except excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for at least 1 month before (female patients only), during, and for at least 3 months after study participation
• See Disease Characteristics
• No prior CEA-directed active immunotherapy
• Prior CEA-directed antibody therapy allowed
• At least 4 weeks since prior immunotherapy and recovered
• No other concurrent antineoplastic biologic therapy or immunotherapy
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No concurrent antineoplastic chemotherapy
• See Disease Characteristics
• No concurrent antineoplastic hormonal therapy
• No concurrent systemic steroids (inhaled steroids allowed)
• Concurrent systemic mineralocorticoids (e.g., megestrol for appetite stimulation or fludrocortisone) allowed
• Concurrent birth control pills allowed
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to more than 50% of all nodal groups
• See Disease Characteristics
• Recovered from prior surgery
• No prior splenectomy
• Concurrent non-steroidal anti-inflammatory drugs allowed
• No other concurrent anti-cancer therapy