Vaccine Therapy in Treating Patients With Stage III, Stage IV, or Relapsed Non-Small Cell Lung Cancer Treated With First-Line Chemotherapy
RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective immune response to kill non-small cell lung cancer cells.
PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with first-line chemotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy|
- Safety [ Time Frame: 6, 12, 18, 24, and 36 months post enrollment ] [ Designated as safety issue: Yes ]
- Immunologic response: CD8, CD4 and NK response [ Time Frame: Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Allogeneic NSCLC/AD100-gp96-ig Vaccine||
Biological: Ad100-gp96Ig-HLA A1
Dose Schedule 1 (DS-1): 4x10^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10^7 cells twice weekly, maximum 36 vaccines/patient
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
- to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC.
- to study the immune response to vaccination,
- to monitor clinical responses and
- to recommend a dose-schedule combination for further testing in an initial Phase II trial of vaccine efficacy.
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Study Chair:||Luis E. Raez, MD, FACP||University of Miami Sylvester Comprehensive Cancer Center|