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Cancer Vaccine

Lung Cancer Vaccine for Lung Cancer Prevention and Recurrence

Phase < 1
Recruiting
Led By Mary Reid, PhD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
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
Must not have
Clinically inappropriate to have a bronchoscopy procedure
Has known immunosuppressive disease (e.g. human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS] or other immune depressing disease). Testing is not mandatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 12 months
Awards & highlights

Summary

This trial is testing a vaccine to prevent lung cancer in patients who are at high risk for the disease or in stage IB-IIIA non-small cell lung cancer survivors to see if it is effective and has minimal side effects.

Who is the study for?
This trial is for high-risk individuals or stage IB-IIIA non-small cell lung cancer survivors without current evidence of cancer. Participants must have a good performance status, agree to contraception if applicable, and not be pregnant. High-risk factors include moderate/severe COPD, family history of lung cancer, low BMI, pneumonia in the last 5 years, exposure to certain substances like asbestos or radon, recent smoking history with significant pack-years.
What is being tested?
The CIMAvax-EGF vaccine is being tested for its ability to prevent the development or recurrence of lung cancer by targeting a protein (EGFR) linked to tumor growth. The study includes questionnaires and quality-of-life assessments alongside the vaccine administration.
What are the potential side effects?
While specific side effects are not listed here, vaccines like CIMAvax-EGF could potentially cause reactions at the injection site, flu-like symptoms such as fever and chills, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I am at high risk for lung cancer due to factors like COPD, family history, low BMI, recent pneumonia, occupational exposure, or smoking history.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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It is not safe for me to undergo a bronchoscopy.
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I have a condition that weakens my immune system, like HIV.
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I am an adult capable of making decisions, not pregnant, and not incarcerated.
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I do not have any uncontrolled illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Molecular biomarker analysis
Number of patients with grade 3, 4 or 5 toxicities that are attributable to recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax)
Vaccination
Secondary study objectives
Change in quality of life scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (recombinant human EGF-rP64K/montanide ISA 51)Experimental Treatment3 Interventions
LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM at 0, 2, 4 and 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM Q4W in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,358 Total Patients Enrolled
Mary Reid, PhDPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04298606 — Phase < 1
Lung Cancer Research Study Groups: Prevention (recombinant human EGF-rP64K/montanide ISA 51)
Lung Cancer Clinical Trial 2023: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Highlights & Side Effects. Trial Name: NCT04298606 — Phase < 1
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298606 — Phase < 1
~3 spots leftby Nov 2024
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