← Back to Search

Cancer Vaccine

Vaccine for Gastrointestinal Cancer

Phase 2
Waitlist Available
Led By Babar Bashir, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Subjects with tumors specified below, who are at high risk of relapse, have been treated with curative intent, and have no evidence of disease (NED) following front-line therapy with surgery, radiation therapy, and/or chemotherapy. NED includes, where applicable, surgical (macroscopic tumor margin, at the time of surgery), and radiological evidence of disease. Residual lesions identified by microscopic/frozen margins and biochemical markers are permitted. Therapy must have been completed no fewer than four weeks, and no later than 25 weeks, before the first dose of Ad5.F35-hGCC-PADRE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights

Study Summary

This trial is testing a vaccine to treat gastrointestinal adenocarcinoma. The vaccine may help the patient's own immune system to kill tumor cells and prevent the cancer from coming back.

Who is the study for?
This trial is for adults with gastrointestinal adenocarcinoma who've had treatment aiming to cure and currently show no signs of the disease. They must be in good physical condition, not have severe kidney issues, use effective contraception if childbearing potential, and not have other serious health problems or a history of certain diseases.Check my eligibility
What is being tested?
The trial is testing a vaccine called Ad5.F35-hGCC-PADRE to see how well it works and what side effects it has on patients with gastrointestinal adenocarcinoma. The goal is for the vaccine to teach the immune system to recognize and kill cancer cells.See study design
What are the potential side effects?
Possible side effects from the Ad5.F35-hGCC-PADRE vaccine may include typical immune responses like soreness at injection site, fever, fatigue or allergic reactions. Since this is an investigational study, there may be some unknown risks as well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are in good enough health to carry out your everyday activities or only have some minor limitations.
Select...
You have had certain types of tumors and have been treated with the goal of curing the cancer. After treatment, there is no sign of the disease, with some exceptions for small remaining tumors or certain test results. Treatment must have finished between four and 25 weeks before starting the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antigen-specific T-cell response to guanylyl cyclase C (GCC)
Incidence of adverse events (AEs)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (high dose)Experimental Treatment1 Intervention
Patients receive high dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (medium dose)Experimental Treatment1 Intervention
Patients receive medium dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (low dose)Experimental Treatment1 Intervention
Patients receive low dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
442 Previous Clinical Trials
145,386 Total Patients Enrolled
Babar Bashir, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

Media Library

Ad5.F35-hGCC-PADRE (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04111172 — Phase 2
Small Intestinal Cancer Research Study Groups: Arm B (medium dose), Arm A (low dose), Arm C (high dose)
Small Intestinal Cancer Clinical Trial 2023: Ad5.F35-hGCC-PADRE Highlights & Side Effects. Trial Name: NCT04111172 — Phase 2
Ad5.F35-hGCC-PADRE (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04111172 — Phase 2

Frequently Asked Questions

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

Are there any vacancies for individuals to join this research endeavor?

"Active recruitment is currently taking place for this trial, as indicated on clinical trials.gov. The initial posting was made on November 10th 2020 and the most recent update to the information occured on November 16th 2022."

Answered by AI

How many participants are currently involved in this trial?

"Affirmative. According to the clinicaltrials.gov database, this study which was first published on November 10th 2020 is actively seeking participants. 81 individuals must be recruited from a single site for full enrollment of the trial."

Answered by AI

Has the FDA sanctioned Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE for medical use?

"With prior safety data, but no clinical efficacy research to draw from, Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE was rated a 2 on our team's scale."

Answered by AI
~19 spots leftby Mar 2025