A Phase II, Open Label, Multi-Center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell lung cancer meeting 1 of the following stage
criteria:

- Stage IIIB disease

- Stage IV disease

- Recurrent disease

- HLA-A2-positive disease

- HLA-A2 negative patients are eligible to enroll in group II (observation) only

- Measurable disease

- Estimated tumor volume ≤ 125 cc

- No CNS signs or symptoms of brain metastases

- Brain metastases that are clinically stable for ≥ 2 months AND do not require
anticonvulsants or systemic steroids are allowed

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 12 weeks

Hematopoietic

- Hemoglobin ≥ 10 g/dL

- Platelet count > 100,000/mm^3

- WBC > 3,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Absolute lymphocyte count > 500/mm^3

Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with
liver involvement by tumor)

- Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor)

- Albumin ≥ 2.5 g/dL

- Alkaline phosphatase ≤ 2.5 times ULN

- No history of hepatitis B or C positivity

Renal

- Creatinine ≤ 2 times ULN

Immunologic

- No history of any of the following active conditions:

- Systemic lupus erythematosus

- Scleroderma

- Connective tissue disease

- Sjögren's syndrome

- Multiple sclerosis

- Rheumatoid arthritis

- Inflammatory bowel disease

- No history of HIV positivity

- No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to
study vaccine or to any of its components

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 weeks after
completion of study treatment

- No other malignancy within the past 5 years except curatively excised nonmelanoma
skin cancer or surgically cured carcinoma in situ of the cervix

- No other acute medical condition that would preclude study treatment

- No mental or psychiatric condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 1 month since prior interferon therapy

- More than 1 month since prior interleukin therapy

- No prior cancer vaccine therapy, including participation in a vaccine study

Chemotherapy

- At least 4 weeks since prior chemotherapy

Endocrine therapy

- See Disease Characteristics

- More than 1 month since prior systemic corticosteroids except stable doses of inhaled
corticosteroids

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- No concurrent participation in another investigational study