• Safety by CTC AE version 3.0 [ Designated as safety issue: Yes ]
  

• Objective response by RECIST every 2 months [ Designated as safety issue: No ]
  
• Compare immunologic response by ELISPOT at baseline and day 91 [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the clinical safety of vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, recombinant fowlpox GM-CSF vaccine, and radiotherapy in patients with carcinoembryonic antigen (CEA)-positive solid tumors metastatic to the liver.

Secondary

• Determine the clinical response in patients receiving this regimen.
• Determine the immunological response, specifically the CEA-specific T-cell response, in patients receiving this regimen.
• Determine the effect of radiotherapy (before and after treatment) on FAS, major histocompatability complex, p53, and CEA in these patients.

OUTLINE: Patients receive a priming vaccination of vaccinia (rV)-CEA-TRICOM and recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine subcutaneously (SC) on day 1. Patients receive a booster vaccination of fowlpox (rF)-CEA-TRICOM and rF-GM-CSF SC on days 21, 35, 49, and 63. Patients undergo radiotherapy on days 22-25, 36-39, 50-53, and 64-67. Patients with stable disease or objective response after day 91 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed annually for 15 years.

PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of solid tumor

  • Radiographically visible metastatic liver lesions that are life-threatening

  • Carcinoembryonic antigen (CEA)-positive disease that meets one of the following criteria:

    • ≥ 20% of cells stained immunohistochemically
    • Elevated serum CEA (> 5 ng/mL) at any time during disease course
• Received at least 1 prior chemotherapy regimen for metastatic disease
• Vaccinia-naïve OR vaccinia-immune
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 6 months

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8 g/dL
• Absolute lymphocyte count ≥ 400/mm^3

Hepatic

• See Disease Characteristics
• AST ≤ 2 times upper limit of normal
• Bilirubin normal (≤ 3 times ULN with Gilbert's syndrome)
• PT and PTT normal
• Hepatitis B and C negative

• No chronic liver disease, including the following:

  • End stage cirrhosis
  • Chronic active hepatitis by surface antigen or core antibody test

Renal

• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No New York Heart Association class II-IV heart disease
• No evidence of congestive heart failure by physical exam or imaging
• No clinically significant cardiomyopathy requiring treatment

Pulmonary

• No pulmonary disease with fatigue or dyspnea after ordinary physical activity

Immunological

• No autoimmune disease, including the following:

  • Addison's disease
  • Hashimoto's thyroiditis
  • Systemic lupus erythematous
  • Sjögren syndrome
  • Scleroderma
  • Myasthenia gravis
  • Goodpasture syndrome
  • Active Grave's disease
• HIV negative
• No allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen
• No serious hypersensitivity reaction to egg products

Other

• During and for at least 3 weeks after vaccinia vaccination, patients or their close household contacts must not have contact with the following individuals:

  • Individuals with active or a history of eczema or other eczematoid skin disorders

  • Individuals with acute, chronic, or exfoliative skin disorders, including any of the following until the condition resolves:

    • Atopic dermatitis
    • Burns
    • Impetigo
    • Varicella zoster
    • Severe acne
    • Other open rashes or wounds
  • Pregnant or nursing women
  • Children ≤ 5 years of age
  • Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV-infected individuals)

• No concurrent serious medical illness that would preclude study compliance, including, but not limited to, the following:

  • Inflammatory bowel disease
  • Crohn's disease
  • Ulcerative colitis
  • Active diverticulitis
• No history of seizures, encephalitis, or multiple sclerosis
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• Prior immunotherapy allowed
• No other concurrent immunotherapy

Chemotherapy

• See Disease Characteristics
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No concurrent chemotherapy

Endocrine therapy

• No concurrent systemic steroids except physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroids
• At least 2 weeks since prior steroid eye drops
• No concurrent steroid eye drops during and for 4 weeks after vaccinia vaccination
• No concurrent hormone therapy
• No concurrent dexamethasone or other steroid as an antiemetic

Radiotherapy

• No prior radiotherapy to > 50% of all nodal groups
• No prior radiotherapy to the whole liver
• No other concurrent radiotherapy

Surgery

• No prior splenectomy
• No concurrent major surgery

Other

• Recovered from all prior therapy
• At least 4 weeks since prior cytotoxic therapy
• No concurrent aprepitant
• No other concurrent anticancer therapy