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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- University of Miami
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Preliminary Safety Profile (Phase 1)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Preliminary Safety Profile (Phase 1)
Time Frame: Up to 13 weeks
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.
Progression-free Survival (Phase 2)
Time Frame: Date of randomization to the earliest date of documented progression.
Secondary Outcomes
- Correlative Immunological Studies in Study Participants (Phase 2)(Baseline, Week 7 and Week 13)
- Safety Profile (Phase 2)(About 13 weeks)
- Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)(About 13 weeks)
- Response to Second-line Chemotherapy After Disease Progression (Phase 2)(From Week 1 of Study Therapy until Death or Withdrawal of Consent)
- Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)(From Week 1 of Study Therapy until Death or Withdrawal of Consent)
- Overall Survival (Phase 2)(Date of randomization to the recorded date of death)