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.
- 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
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.
- Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer
- Tumor diameter of at least 3 cm
- 18 to 75
- ECOG 0-2
- At least 3 months
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- 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
- Creatinine no greater than 1.4 mg/dL
- 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:
- At least 4 weeks since prior biological materials
- At least 4 weeks since prior cytotoxic or chemotherapeutic agents
- Concurrent chemotherapy allowed after surgery and before vaccination
- No concurrent steroid therapy
- At least 4 weeks since prior radiotherapy
- Concurrent radiotherapy allowed after surgery and before vaccination
- See Disease Characteristics