Vaccine Therapy in Treating Patients With Stage III, Stage IV, or Relapsed Non-Small Cell Lung Cancer Treated With First-Line Chemotherapy

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Biological: Ad100-gp96Ig-HLA A1

• Registration Number: NCT00503568
• Lead Sponsor: University of Miami

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.

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DS-1: gp96-ig Dose Schedule 1	Ad100-gp96Ig-HLA A1	Dose Schedule 1 (DS-1): Ad100-gp96Ig-HLA A1 Vaccine 4x10\^7 cells bi-weekly, maximum 9 vaccines/patient;
DS-2: gp96-ig Dose Schedule 3	Ad100-gp96Ig-HLA A1	Dose Schedule 2 (DS-2): Ad100-gp96Ig-HLA A1 Vaccine 2X10\^7 cells weekly, maximum 18 vaccines/patient;
DS-3: gp96-ig Dose Schedule 3	Ad100-gp96Ig-HLA A1	Dose Schedule 3 (DS-3): Ad100-gp96Ig-HLA A1 Vaccine 1x10\^7 cells twice weekly, maximum 36 vaccines/patient

Primary Outcome Measures

Name	Time	Method
Safety	6, 12, 18, 24, and 36 months post enrollment

Secondary Outcome Measures

Name	Time	Method
Immunologic response: CD8, CD4 and NK response	Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States