← Back to Search

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

No Placebo-Only Group

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

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

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:

Select...

It is not safe for me to undergo a bronchoscopy.

Select...

I have a condition that weakens my immune system, like HIV.

Select...

I am an adult capable of making decisions, not pregnant, and not incarcerated.

Select...

I do not have any uncontrolled illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 12 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met