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Cancer Vaccine
MUC1 Vaccine + PolyICLC for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Arjun Pennathur, MD
Research Sponsored by Olivera Finn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have stable disease at the time of enrollment
ECOG performance status 0-1(Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test a new vaccine for people with non-small cell lung cancer. The vaccine will be given every 3 weeks for 3 doses, and then yearly for up to 5 years for people who respond well to the vaccine.
Who is the study for?
This trial is for adults with stable non-small cell lung cancer who are within 4-24 weeks post-standard treatment. They must have good organ and marrow function, no autoimmune diseases, not be on immune therapies or steroids, and agree to use contraception. Those with a history of certain cancers or serious illnesses are excluded.Check my eligibility
What is being tested?
The study tests a MUC1 peptide vaccine combined with PolyICLC given subcutaneously every three weeks for three doses, plus optional yearly boosters up to five years for responders. It aims to stimulate an immune response against lung cancer cells without causing significant toxicity.See study design
What are the potential side effects?
No significant toxicity has been observed in similar ongoing trials using the same vaccine formulation. However, as it's an immunotherapy, potential side effects may include mild injection site reactions or flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease has not worsened recently.
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I am fully active or can carry out light work.
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My blood tests show my organs are functioning well.
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My cancer is confirmed as non-small cell lung cancer or neuroendocrine carcinoid tumor.
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My cancer is at an early or mid-stage, not the most advanced.
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I am 18 years old or older.
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I started my standard cancer treatment between 1 to 6 months ago.
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I am willing to use effective birth control during and for 3 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunologic response
Secondary outcome measures
Anti-MUC1 immunity
Association between baseline MUC1 immunity and vaccine
Immunocompetence versus immunosuppression
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Stage IIIA or IIIBExperimental Treatment1 Intervention
Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
Group II: Stage IB/II/IIIAExperimental Treatment1 Intervention
Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Group III: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumorExperimental Treatment1 Intervention
Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
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Who is running the clinical trial?
Olivera FinnLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
Arjun Pennathur, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
1 Previous Clinical Trials
6,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My disease has not worsened recently.I am fully active or can carry out light work.My blood tests show my organs are functioning well.I have never had cancer, except possibly for non-melanoma skin cancer.I am not taking steroids or any immune system treatments currently.I do not have a serious infection or condition that would prevent me from receiving treatment.I started my standard cancer treatment less than 6 months ago.My cancer is confirmed as non-small cell lung cancer or neuroendocrine carcinoid tumor.My cancer is at an early or mid-stage, not the most advanced.I am 18 years old or older.I am being treated for Hepatitis B with immune system medications.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am being treated for Hepatitis C with immune system medications.I do not have HIV.I have not received any vaccine therapy before.I started my standard cancer treatment between 1 to 6 months ago.I am willing to use effective birth control during and for 3 months after the study.I had lung cancer surgery at least 5 years ago.If you have a positive ANA test result higher than 1:160, you won't be able to join the study. If your ANA test result is weakly positive, up to 1:160, and you don't have any symptoms, you may still be able to join the study.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor
- Group 2: Stage IB/II/IIIA
- Group 3: Stage IIIA or IIIB
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers still being sought for this research project?
"Yes, the trial is still looking for participants. According to the clinicaltrials.gov website, the study was first advertised on November 1st, 2012 and updated as recently as May 26th, 2022."
Answered by AI
How many people are receiving care in this experiment?
"That is accurate. The information available on clinicaltrials.gov implies that this study, which was established on November 1st 2012, has an open call for patients. They are looking for 30 individuals total from a single location."
Answered by AI
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