Status:
RECRUITING
A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Chronic Obstructive Pulmonary Disease
Lung Non-Small Cell Carcinoma
Eligibility:
All Genders
50-79 years
Phase:
EARLY_PHASE1
Brief Summary
This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or com...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies. II. To access the molecular profile of blood, bronchial and nasal brushes, and bronc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 22 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04298606
Start Date
November 22 2021
End Date
November 22 2029
Last Update
May 2 2025
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263