Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer
National Cancer Institute (NCI)
Summary
This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.
Description
PRIMARY OBJECTIVE: I. To evaluate the effect of SVN53-67/M57-KLH peptide vaccine (SurVaxM) administration on the generation of a systemic anti-survivin immune response. SECONDARY OBJECTIVES: I. To assess the proportion of participants needing a 3-month booster dose to achieve seroconversion. II. To assess the proportion of participants mounting a cellular immune response to SurVaxM vaccination. III. To assess the safety profile of SurVaxM administration in this population. EXPLORATORY OBJECTIVES: I. To associate participants' demographic and clinical characteristics with outcomes (seroc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Former and current smokers (male and female) with a \>= 20 pack year smoking history * Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score \> 1.34% * Participants \>= 18 years old will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of SurVaxM in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%) * Platelets…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugMontanide ISA 51 VG
Given SC
- OtherQuestionnaire Administration
Ancillary studies
- BiologicalSargramostim
Given SC
- BiologicalSVN53-67/M57-KLH Peptide Vaccine
Given SC
Locations (4)
- Rocky Mountain Regional VA Medical CenterAurora, Colorado
- Northwestern UniversityChicago, Illinois
- Roswell Park Cancer InstituteBuffalo, New York
- University of Tennessee - KnoxvilleKnoxville, Tennessee