Vaccine Study for Treating Gastrointestinal Cancers

Sponsor: Thomas Jefferson University

Sponsor score: 0

ClinicalTrials ID:NCT04111172

Provider View

This clinical trial is testing a new vaccine, Ad5.F35-hGCC-PADRE, to see if it can help the immune system fight and prevent the return of gastrointestinal cancers like colorectal, pancreatic, gastric, or esophageal adenocarcinoma.

Patient Parameters

Program Overview

This study is exploring the effects of a new vaccine, Ad5.F35-hGCC-PADRE, on patients with certain gastrointestinal cancers. The vaccine aims to train the immune system to recognize and destroy cancer cells, potentially preventing the cancer from coming back. The trial will assess the safety of the vaccine and how well it works in patients who have had surgery and standard treatments and currently show no signs of cancer.

Description

The main goals of this study are to determine if the Ad5.F35-hGCC-PADRE vaccine is safe and to see how the immune system responds to it. The vaccine is given as a shot in the muscle three times, with different doses being tested. Patients in the study have had surgery and standard treatments for high-risk colorectal, pancreatic, gastric, or esophageal cancers and currently show no signs of disease.

The study will also look at how the immune system reacts to the vaccine by measuring certain immune responses over time. Researchers will monitor patients for any side effects and track their health to see if the vaccine helps keep the cancer from returning.

Participants are divided into three groups, each receiving a different dose of the vaccine. After completing the vaccine doses, patients will have follow-up visits to check their health and monitor for any signs of cancer returning. These follow-ups will occur 28 days after the last vaccine dose and then every three months for at least two years.

Eligibility Criteria

Inclusion Criteria

  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have had surgery and standard treatments for high-risk colorectal, pancreatic, gastric, or esophageal cancer and currently show no signs of disease.
  • Have completed treatment at least four weeks ago but not more than 25 weeks ago.
  • Have a life expectancy of more than 12 weeks.
  • Meet specific blood test requirements, including:
    • Neutrophil count of at least 1000 cells/mL.
    • Platelet count of at least 75,000/mL.
    • Hemoglobin level of at least 9.0 g/dL.
    • Serum creatinine level below 2.0 mg/dL.
  • Use effective birth control methods during the study and for 28 days after the last vaccine dose if of childbearing potential.
  • Be willing to follow all study procedures and sign an informed consent form.

Exclusion Criteria

  • Have any remaining cancer after surgery.
  • Have cancer that has spread to the brain or central nervous system.
  • Have received immunotherapy or experimental treatments after standard therapy.
  • Have had a splenectomy or distal pancreatectomy.
  • Be using systemic steroids or immunosuppressive drugs (except topical or inhaled steroids).
  • Have an immune deficiency or compromised immune system.
  • Have an active or history of autoimmune disease or require immunosuppressive treatment.
  • Have HIV, hepatitis B, or hepatitis C (unless hepatitis C is controlled).
  • Have had another cancer within the last five years, except for certain skin or cervical cancers.
  • Have inflammatory bowel disease.
  • Have had a serious reaction to adenovirus.
  • Have a serious illness that could affect study participation.
  • Have poor vein access for blood draws.
  • Consume more than three alcoholic drinks per day and cannot abstain during the study.
  • Use illicit drugs that could affect study participation.
  • Be pregnant or breastfeeding.
  • Have an unhealed surgical wound.
  • Have had major surgery or injury within 28 days before starting the study or need surgery during the study.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Cancer Center at Thomas Jefferson University19107PhiladelphiaPennsylvania

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