Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES:

Primary

* Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only.
* Determine the safety of this vaccine in these patients.

Secondary

* Determine progression-free survival of patients treated with this vaccine.
* Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine.

OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.

* Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15.
* Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.

Eligibility 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