Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
This trial is active, not recruiting.
|Treatments||ep-2101, incomplete freund's adjuvant|
|Start date||December 2004|
|Trial identifier||NCT00104780, CDR0000415721, EPIMMUNE-EP2101-201, MCMRC-0461|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Ocoee, FL||Cancer Centers of Florida - Ocoee||no longer recruiting|
|Albany, NY||New York Oncology Hematology, P. C. at Albany Regional Cancer Care||no longer recruiting|
|Durham, NC||Duke Comprehensive Cancer Center||no longer recruiting|
|Kettering, OH||Dayton Oncology & Hematology, P.A. - Kettering||no longer recruiting|
|Greenville, SC||Cancer Centers of the Carolinas - Eastside||no longer recruiting|
|Nashville, TN||Sarah Cannon Cancer Center at Centennial Medical Center||no longer recruiting|
|Dallas, TX||Mary Crowley Medical Research Center at Sammons Cancer Center||no longer recruiting|
|Tyler, TX||Tyler Cancer Center||no longer recruiting|
|Spokane, WA||Cancer Care Northwest - North||no longer recruiting|
Comparison of overall survival with historical controls
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
Male or female participants at least 18 years old.
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
|Official title||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)|
|Description||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.|
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