Vaccine to prevent lung cancer development or recurrence
A Phase 0 Study of CIMAvax-EGF Vaccine in Patients Who Are at High Risk for Lung Cancer and Lung Cancer Survivors at Risk for Recurrence
This study is testing a new vaccine to see if it can help prevent lung cancer from developing or coming back in people who are at high risk.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 79 Years |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT04298606 on ClinicalTrials.gov |
What this trial studies
This early phase I trial evaluates the safety and efficacy of the CIMAvax-EGF vaccine in preventing lung cancer in patients at high risk for developing or recurring lung cancer. The study involves administering the vaccine to participants who have no evidence of cancer and assessing their immune response through circulating EGF and anti-EGF antibodies. Additionally, the trial aims to identify molecular markers associated with treatment response and evaluate changes in quality of life during the treatment. Participants will receive the vaccine in a loading phase followed by a maintenance phase, with follow-up for 60 days post-treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of stage IB-IIIA non-small cell lung cancer who are currently cancer-free and have at least one documented risk factor for lung cancer.
Not a fit: Patients with active cancer or those who do not meet the eligibility criteria, such as having an ECOG performance status greater than 2, may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce the risk of lung cancer development or recurrence in high-risk patients.
How similar studies have performed: While there have been studies targeting EGFR in lung cancer, the specific approach of using CIMAvax-EGF as a preventive vaccine is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed no evidence of cancer on computed tomography (CT) scan within 6 months prior to starting treatment * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Patients must have platelets \>= 100 x 10\^9/L * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure * PATIENTS AT HIGH-RISK FOR LUNG CANCER COHORT ONLY (COHORT A) * Must have documented at least one risk factor for lung cancer which includes: * Moderate to severe chronic obstructive pulmonary disease (COPD) defined as FEV1/FVC ratio \<=75% * Positive family history of lung cancer defined as a first degree relative * Low body mass index (BMI) * History of pneumonia within the last 5 years prior to enrollment * Occupational exposure such as asbestos, radon and any other that investigator would deem high risk * Must have quit smoking =\< 15 years ago or be a current smoker * Must have at least 30 pack year smoking history * Must have documented pulmonary function test within the last 3 years prior to enrollment. If a patient cannot tolerate a pulmonary function test, an incentive spirometry will be acceptable in place of a pulmonary function test * LUNG CANCER SURVIVOR COHORT ONLY (COHORT B) * 1. If patient received surgery or any adjuvant therapy for initial diagnosis of lung cancer, it must have been completed at least 3 months prior to enrollment. Prior surgery or any therapy is not required for eligibility * Confirmed non-small cell lung cancer (NSCLC) stage IA through 3A at initial diagnosis Exclusion Criteria: * Clinically inappropriate to have a bronchoscopy procedure * Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, history of clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug * Received an investigational agent within 30 days prior to enrollment * Has known immunosuppressive disease (e.g. human immunodeficiency virus \[HIV\], acquired immunodeficiency syndrome \[AIDS\] or other immune depressing disease). Testing is not mandatory * Patient has known hypersensitivity to the components of the study drugs or any analogs * History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible. Systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment * The following special populations are excluded from this study: * Cognitively impaired adults/adults with impaired decision-making capacity * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Pregnant women
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mary Reid, PhD — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.