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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
Be older than 18 years old
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 belowSelect...
You are in good enough health to carry out your everyday activities or only have some minor limitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
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.
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,606 Total Patients Enrolled
Babar Bashir, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You have received immunotherapy or experimental medications after finishing standard treatment.You still have signs of the disease even after having surgery to remove it.You have cancer that has spread to your brain or central nervous system.You have had your spleen removed in the past.You have had surgery to remove the end of your pancreas.You are currently taking strong medications that weaken your immune system, except for certain types of steroids used on the skin or inhaled.Your body has enough white blood cells called neutrophils.You don't have enough access to your veins for the required blood tests.You are in good enough health to carry out your everyday activities or only have some minor limitations.You have a weakened immune system, such as from taking certain medications or recent chemotherapy or radiation therapy.You have a current or past autoimmune disease, or have had an organ transplant and need to take strong medicines that weaken your immune system.You have HIV, hepatitis B, or hepatitis C. If you have hepatitis C, you can still participate if your viral load is negative.You have had any other type of cancer within the past 5 years, except for non-melanoma skin cancer, early-stage prostate cancer, or a specific type of cervical cancer.You have a history of inflammatory bowel disease.You drink more than three glasses of alcohol per day and cannot stop drinking for the trial.You have used illegal drugs that could make it hard for you to follow the study rules.You have a surgical wound that has not healed yet.You had a severe reaction to adenovirus in the past.You need to have at least 75,000 platelets per milliliter of blood.Your hemoglobin level is at least 9.0 grams per deciliter.Your blood creatinine level is less than 2.0 mg/dL.Your blood and urine test results should not show significant abnormalities according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (medium dose)
- Group 2: Arm A (low dose)
- Group 3: Arm C (high dose)
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.
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