Vaccination of Stage IV NSCLC Patients With a Carbohydrate Mimotope Vaccine
Conditions
Lung Neoplasms
Conditions: official terms
Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: P10s-PADRE vaccine Type: Biological
Name: Placebo Type: Biological
Overall Status
Not yet recruiting
Summary
The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in patients of all races with stage IV Non-Small Cell Lung Cancer who have completed their primary chemotherapy without progressing, and who still have measurable residual disease.

A randomized double-blind placebo-controlled trial is designed with the goal being to evaluate the efficacy of the vaccine. Efficacy will be based primarily on the tumor response, and secondarily on progression-free survival. Information on safety and tolerability will be collected. Humoral and cellular immune responses will be analyzed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- stage IV Non-Small Cell Lung Cancer

- completed their primary chemotherapy

- achieved either stable disease or partial response with measurable residual disease

Exclusion Criteria:

- Women who are pregnant or breast-feeding.

- Patients who have autoimmune disease or are immunosuppressed or receiving systemic corticosteroids
Locations
Highlands Oncology Group
Fayetteville, Arkansas, United States
Status:
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Status: Not yet recruiting
Contact: Konstantinos Arnaoutakis, MD - karnaoutakis@uams.edu
Start Date
June 2015
Completion Date
June 2017
Sponsors
University of Arkansas
Source
University of Arkansas
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page