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

Roswell Park Cancer Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

autologous tumor cell vaccineBIOLOGICAL

therapeutic autologous dendritic cellsBIOLOGICAL

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Data from ClinicalTrials.gov

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