Lung Cancer Clinical Trial
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
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.
Overall Goals:
- 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.
Primary Aim:
- 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.
Secondary Aims:
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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