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Cancer Vaccine

Lung Cancer Vaccine for Lung Cancer Prevention and Recurrence

Q: What is the customary application of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine?

Recombinant Human EGF-rP64K/Montanide ISA 51 <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> is an effective remedy when it comes to second degree burns and other issues such as wounds, ulcers or organ transplantation.

Q: Do I meet the requirements to join this research endeavor?

The current trial is recruiting 60 elderly patients (ages 50-79) afflicted with pneumonia. To qualify, applicants must have platelet counts of at least 100 x 10^9/L, understand the research nature of this study and sign a written informed consent form prior to any procedures, display no evidence of <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> on their CT scan within 6 months before treatment begins, possess an ECOG performance status =&#x3C; 2, women capable of <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a> should commit to using adequate contraceptive methods for contraception or abstinence during participation in this study; if pregnant while involved any suspected pregnancies should be reported immediately to treating physicians. Furthermore individuals partaking in Cohort A who

Q: What is the aggregate number of participants in this research endeavor?

Affirmative. According to clinicaltrials.gov, this medical research project is currently recruiting participants - it was initially posted on November 22nd 2021 and has been periodically updated since then with the latest update being October 20th 2022. The trial requires 60 individuals from 1 centre for successful completion.

Q: Does this trial permit enrollees who are octogenarians?

This medical trial is limited to adults aged 50 to 79. There are 246 studies for participants younger than 18 years old and an additional 3381 trials suitable for those over the age of 65.

Q: Is enrollment still available for this trial?

Affirmative. Clinicaltrials.gov reveals that, since its initial posting on November 22nd 2021, this trial is actively recruiting patients. 60 participants are required from 1 clinical site for the study to be successful.

Q: Has this research endeavor been attempted before?

Currently, 5 ongoing clinical trials are being conducted for Recombinant Human EGF-rP64K/Montanide ISA 51 <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> in 9 cities across two nations. The inaugural investigation of this drug was sponsored by Boehringer Ingelheim and involved 50 trialists completing Phase 2 approval back in 2015 - an event which has since been followed up with 235 further studies.

Q: Has there ever been a study of the effects of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine on humans?

Presently, 5 studies of the Recombinant Human EGF-rP64K/Montanide ISA 51 <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> are ongoing with one trial in Phase 3. While Shenyang, Liaoning is hosting a significant amount of them, there are 10 research centers total that have trials open for this vaccine.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

31,066 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the customary application of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine?

"Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine is an effective remedy when it comes to second degree burns and other issues such as wounds, ulcers or organ transplantation."

Answered by AI

Do I meet the requirements to join this research endeavor?

"The current trial is recruiting 60 elderly patients (ages 50-79) afflicted with pneumonia. To qualify, applicants must have platelet counts of at least 100 x 10^9/L, understand the research nature of this study and sign a written informed consent form prior to any procedures, display no evidence of cancer on their CT scan within 6 months before treatment begins, possess an ECOG performance status =< 2, women capable of pregnancy should commit to using adequate contraceptive methods for contraception or abstinence during participation in this study; if pregnant while involved any suspected pregnancies should be reported immediately to treating physicians. Furthermore individuals partaking in Cohort A who"

Answered by AI

What is the aggregate number of participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical research project is currently recruiting participants - it was initially posted on November 22nd 2021 and has been periodically updated since then with the latest update being October 20th 2022. The trial requires 60 individuals from 1 centre for successful completion."

Answered by AI

Does this trial permit enrollees who are octogenarians?

"This medical trial is limited to adults aged 50 to 79. There are 246 studies for participants younger than 18 years old and an additional 3381 trials suitable for those over the age of 65."

Answered by AI

Is enrollment still available for this trial?

"Affirmative. Clinicaltrials.gov reveals that, since its initial posting on November 22nd 2021, this trial is actively recruiting patients. 60 participants are required from 1 clinical site for the study to be successful."

Answered by AI

Has this research endeavor been attempted before?

"Currently, 5 ongoing clinical trials are being conducted for Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine in 9 cities across two nations. The inaugural investigation of this drug was sponsored by Boehringer Ingelheim and involved 50 trialists completing Phase 2 approval back in 2015 - an event which has since been followed up with 235 further studies."

Answered by AI

Has there ever been a study of the effects of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine on humans?

"Presently, 5 studies of the Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine are ongoing with one trial in Phase 3. While Shenyang, Liaoning is hosting a significant amount of them, there are 10 research centers total that have trials open for this vaccine."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence

2021. "A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04298606.

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