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