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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: EP-2101
* Biological: incomplete Freund's adjuvant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: EP-2101|nan|
|Biological: incomplete Freund's adjuvant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of overall survival with historical controls |  |  | 
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer