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.

Condition	Treatment or Intervention	Phase
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer	Drug: EP-2101  Drug: Montanide ISA-51  Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Florida
      Cancer Centers of Florida - Ocoee, Ocoee,  Florida,  34761,  United States; Recruiting
New York
      New York Oncology Hematology, P.C. at Albany Regional Cancer Care, Albany,  New York,  12208,  United States; Recruiting
Ohio
      Dayton Oncology & Hematology, P.A. - Dayton, Dayton,  Ohio,  45439,  United States; Recruiting
South Carolina
      Cancer Centers of the Carolinas - Eastside, Greenville,  South Carolina,  29615,  United States; Recruiting
Texas
      Mary Crowley Medical Research Center at Sammons Cancer Center, Dallas,  Texas,  75246,  United States; Recruiting
      Tyler Cancer Center, Tyler,  Texas,  75702,  United States; Recruiting
Washington
      Cancer Care Northwest - Spokane North, Spokane,  Washington,  99218,  United States; Recruiting

Study chairs or principal investigators

Scott Plasman,  Study Chair,  Epimmune   

Study ID Numbers:  CDR0000415721; EPIMMUNE-EP2101-201; MCMRC-0461; NCT00104780
Record last reviewed:  February 2005
Last Updated:  March 15, 2005
Record first received:  March 3, 2005
ClinicalTrials.gov Identifier:  NCT00104780
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08