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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00023985

Enrollment

Unknown

Registered

2003-01-27

Start date

2001-01-31

Completion date

2003-08-31

Last updated

2011-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

Brief summary

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

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.

Interventions

BIOLOGICALautologous tumor cell vaccine

BIOLOGICALtherapeutic autologous dendritic cells

PROCEDUREconventional surgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026