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
- To establish safety of the B7 vaccine when used within 4 weeks of completing first line
platinum based chemotherapy. (Phase I)
- To determine whether patients with advanced non-small cell lung cancer (stages IIIB/IV)
who achieve a clinical response (stable disease, partial response, or complete
response) on first-line platinum-based chemotherapy have an increased time to disease
progression as a result of vaccination with an allogeneic B7.1 and HLA-A1 transfected
tumor-cell vaccine. (Phase II)
- To evaluate the immune response (CD8) in B7-vaccinated patients as compared to
controls. (Phase II)
- To evaluate the relationship of CD8 response in B7-vaccinated patients with
progression-free survival. (Phase II)
- To evaluate the safety profile of the B7 vaccine. (Phase II)
- To evaluate the response rates on second-line chemotherapy (after disease progression)
in the B7-vaccinated patients as compared to controls. (Phase II)
- To evaluate the overall survival in patients immunized with B7 vaccine as compared to
controls. (Phase II)
- To evaluate the correlative immunological studies. (Phase II)
OUTLINE: This is a multicenter study.
- Phase I (single site [University of Miami Sylvester Comprehensive Cancer Center]):
Patients receive allogeneic B7.1 and 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
- 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
CD8, CD4, and NK response and PBL and TH1/TH2 bias, including levels of IL-1β,
IL-2, IL-4, IL-5, IL-6, IL-13, IFN-γ, 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Preliminary Safety Profile (Phase I)
This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.
Luis E. Raez, MD, FACP
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|
|Memorial Regional Hospital||Hollywood, Florida 33021|