Vaccination of Advanced-Stage Lung Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02264236|
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : February 2, 2018
The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial.
This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Biological: P10s-PADRE vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"Vaccination of Advanced-Stage Lung Cancer Patients" A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||November 2021|
Experimental: P10s-PADRE vaccine
Subjects will be immunized by administration of either three or four doses of P10s-PADRE vaccine over a six-week period at a dose level of 500 micrograms (µg) per injection depending on the slandered of care therapy they receive for their lung cancer.
Biological: P10s-PADRE vaccine
P10s-PADRE vaccine combined with MONTANIDE™ ISA 51 VG "Chemotherapy" Subcutaneous injection at weeks 2, 3, 5, and 6. "3-Week Interval Immunotherapy" Subcutaneous injection at weeks 2, 3, and 4. "2-Week Interval Immunotherapy" Subcutaneous injection at weeks 3, 4, and 5.
Other Name: Mimotope P10s-PADRE Vaccine
- Number of participants with vaccine related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. [ Time Frame: 64 weeks +/- 2 weeks per subject ]The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has published standardized definitions for adverse events (AEs), known as the Common Terminology Criteria for Adverse Events (CTCAE, also called "common toxicity criteria"), to describe the severity of organ toxicity for patients receiving cancer therapy. The tables describing AEs graded in the CTCAE (version 4.0) provides a references for adverse events reporting. From grade 1 AEs being minor/low grade adverse events to grade 5 AEs being serious adverse events usually resulting in death.
- Number of participants with vaccine induced immune related response. [ Time Frame: 64 weeks +/- 2 weeks per subject ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264236
|Contact: Konstantinos Arnaoutakis, MD||Karnaoutakis@uams.edu|
|United States, Arkansas|
|University of Arkansas for Medical Sciences||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Konstantinos Arnaoutakis, MD email@example.com|
|Principal Investigator:||Konstantinos Arnaoutakis, MD||University of Arkansas|