Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01504542|
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : January 5, 2012
Last Update Posted : November 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Biological: HS110 vaccine Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Immune Response, Safety and Efficacy of HS-110 in Combination With Erlotinib vs. Erlotinib as a Single Agent in Patients With Advanced, Non-EGFR Mutated Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Low-dose HS-110
2,000,000 cells/0.5mls + erlotinib 150mg orally once daily
Biological: HS110 vaccine
0.5ml to be administered twice weekly for 18 weeks (36 doses)
Experimental: High dose HS110
10,000,000 HS110 cells/0.5ml + erlotinib 150mg orally once daily.
Biological: HS110 vaccine
0.5 mls to be dosed twice weekly for 18 weeks (36 doses)
Placebo Comparator: Placebo vaccine + erlotinib 150mg orally once daily
Placebo vaccine buffered saline solution + erlotinib 150mg orally once daily
0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)
- Immunologic Response (defined as production of IFNƴ from CD8+ T cells as evaluated by ELISPOT assay) [ Time Frame: Week 18 ]Immune response will be evalulated by ELISPOT assays and change will be assessed from baseline.
- Safety of the combination of HS110 vaccine and erlotinib [ Time Frame: Up to 1 year ]Incidence and severity of adverse events, changes in laboratory measures, physical exams and evaluation of autoimmune phenomena.
- Tumor assessment by immunologic response criteria (irRC) [ Time Frame: Baseline, Week 12 and Week 22 ]Patients will have a CT scan performed at baseline, Week 12 and Week 22 or at the end of study visit in the case of early termination from study. Investigators will assess the disease response using irRC for overall response, CR, PR, SD or PD.
- Exploratory Immunologic endpoint - evaluation of circulating tumor cells [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18 ]Analysis via a semiautomated, epithelial cell adhesion molecule-based immunomagnetic technique.
- Exploratory immunologic endpoint - immune function [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18 ]Analysis of cell surfance molecules by flow cytometry
- Exploratory immunologic endpoint - proteomic profile [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18 ]Examination of protein expression utilizing western blot, immunohistochemical staining, enzyme linked immunosorbent assay (ELISA) or mass spectrometry
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504542
|United States, Texas|
|Mary Crowley Cancer Research Centers|
|Dallas, Texas, United States, 75201|
|Principal Investigator:||John Nemunaitis, MD||Mary Crowley Cancer Research Centers|