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Vaccine for Gastrointestinal Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm B (medium dose)
- Group 2: Arm A (low dose)
- Group 3: Arm C (high dose)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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