Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer. Determine the immunologic response in patients treated with this vaccine. OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.

Official Title
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Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: autologous tumor cell vaccine
* Biological: therapeutic autologous dendritic cells
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer Tumor diameter of at least 3 cm PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST less than 2 times upper limit of normal (ULN) Lactate dehydrogenase less than 2 times ULN Hepatitis B and C negative Renal: Creatinine no greater than 1.4 mg/dL Other: Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test) HIV negative No active systemic infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biological materials Chemotherapy: At least 4 weeks since prior cytotoxic or chemotherapeutic agents Concurrent chemotherapy allowed after surgery and before vaccination Endocrine therapy: No concurrent steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy Concurrent radiotherapy allowed after surgery and before vaccination Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: autologous tumor cell vaccine|nan|
|Biological: therapeutic autologous dendritic cells|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer