Lung Cancer Clinical Trial
Official title:
Phase I/II Clinical Trial of Immunotherapy With an Allogeneic B7.1/HLA-A1 Transfected Tumor Cell Vaccine in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer That Have Completed First Line Chemotherapy
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune
response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and
to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung
cancer who have finished first-line chemotherapy.
OUTLINE: This is a multicenter study.
- Phase I (single site [University of Miami Sylvester Comprehensive Cancer Center]):
Patients receive allogeneic B7.1 and human leukocyte antigen-A1 (HLA-A1) transfected
tumor cell vaccine intradermally (ID) in weeks 1, 3, and 5. Treatment repeats every 6
weeks for 2 courses. If no more than 1 of 6 patients experience a probable or
definitively treatment related adverse effect (i.e., grade 2 autoimmune or grade 3-4 of
any type), patients proceed to the phase II portion of the study. If 2 or more (out of
6) patients experience treatment related adverse effects the study stops.
- Phase II (randomized): Patients are stratified according to study site (University of
Miami Sylvester Comprehensive Cancer Center or Memorial Regional Hospital), type of
prior first-line treatment (platinum and taxane vs platinum and gemcitabine), and
presence of brain metastasis (yes vs no). Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive allogeneic B7.1 and HLA-A1 transfected tumor cell vaccine
ID in weeks 1, 3, and 5. Treatment repeats every 6 weeks for 2 courses.
- Arm II: Patients receive a placebo vaccine as in arm I. Patients undergo blood
sample collection periodically for correlative studies. Samples are analyzed for
cluster of differentiation 8 (CD8), cluster of differentiation 4 (CD4), and natural
killer cell (NK) response and peripheral blood lymphocytes (PBL) and T helper cell
1 (TH1)/T helper cell 2 (TH2) bias, including levels of interleukin (IL) IL-1β,
IL-2, IL-4, IL-5, IL-6, IL-13, Interferon-gamma (IFN-γ), tumor necrosis
factor-alpha (TNF-α) via ELISA.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 4 years, and then once a year thereafter.
PROJECTED ACCRUAL: A total of 66 patients (6 patients for phase I and 60 patients for phase
II) will be accrued for this study.
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