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Cancer Vaccine

PalloV-CC for Colon Cancer

Phase 1
Waitlist Available
Led By George Peoples, MD
Research Sponsored by George E. Peoples
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year for all 4 cohorts to enroll and undergo treatment.
Awards & highlights

Study Summary

This trial is testing a new cancer vaccine by comparing it to past treatments. Patients will serve as their own controls by comparing their tumor's immunity before and after treatment. The study will enroll patients consecutively and in overlapping cohorts to test different doses of the vaccine.

Eligible Conditions
  • Colon Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year for all 4 cohorts to enroll and undergo treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for all 4 cohorts to enroll and undergo treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Immunologic Endpoint-Overall Immunoscore of the tumor microenvironment
Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumor microenvironment
Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
+1 more
Secondary outcome measures
Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment
Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore
Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: 8x10^8 particles of PalloV-CCExperimental Treatment1 Intervention
Intradermal injection of PalloV-CC weekly x 4 weekly
Group II: 4x10^8 particles of PalloV-CCExperimental Treatment1 Intervention
Intradermal injection of PalloV-CC weekly x 4 weekly
Group III: 2x10^8 particles of PalloV-CCExperimental Treatment1 Intervention
Intradermal injection of PalloV-CC weekly x 4 weekly
Group IV: 1x10^8 particles of PalloV-CCExperimental Treatment1 Intervention
Intradermal injection of PalloV-CC weekly x 4 weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PalloV-CC
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

George E. PeoplesLead Sponsor
1 Previous Clinical Trials
275 Total Patients Enrolled
PalloV, LLCUNKNOWN
George Peoples, MDPrincipal InvestigatorCancer Insight
1 Previous Clinical Trials
26 Total Patients Enrolled

Frequently Asked Questions

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

What are the main purposes of this experiment?

"This medical study aims to evaluate the Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumour microenvironment over a period of approximately 1 year for all 4 cohorts enrolled. Additionally, Secondary objectives include comparing CD4+ and regulatory T cells expression within the Tumor Microenvironment, determining concordance between Immunoscore (scale range: low, intermediate, high) with other analytical tools such as gene expression data analysis (CIBERSORT) and T-cell receptor sequencing (Immunoseq), plus examining PD-L1 expression on tumor cells from pretreatment endoscopic biopsies, post"

Answered by AI

How many people are eligible to take part in this clinical experiment?

"Affirmative. Evident from the information on clinicaltrials.gov, this medical trial is still accepting participants and was initially posted July 20 2019 with its most recent update made September 14 2022. The study necessitates 24 patients be recruited from a single location."

Answered by AI

Has the FDA approved PalloV-CC for use in medical treatments?

"The clinical data surrounding PalloV-CC's safety is sparse, so it earned a score of 1."

Answered by AI

Is there space for more participants in this research study?

"Affirmative. According to the information hosted by clinicaltrials.gov, this investigation is currently recruiting patients that meet its criteria. The study was first published on July 20th 2019 and recently updated on September 14th 2022; 24 individuals are needed from a single site for enrollment purposes."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
Clinical Associates of Research Therapeutics of America
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Trial of PalloV-CC in Colon Cancer
George E. Peoples 2019. "Trial of PalloV-CC in Colon Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03827967.
~4 spots leftby Apr 2025
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