Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-06-26 @ 4:06 AM
Study NCT ID:
NCT00503568
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2007-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Stage III, Stage IV, or Relapsed Non-Small Cell Lung Cancer Treated With First-Line Chemotherapy
Sponsor:
University of Miami
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
\- 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: