Vaccine for Gastrointestinal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBabar Bashir, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase IIA trial investigates the side effects of Ad5.F35-hGCC-PADRE vaccine and to see how well it works in treating patients with gastrointestinal adenocarcinoma. Ad5.F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.

Eligibility Criteria

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.

Inclusion 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.

Have an anticipated life expectancy of greater than 12 weeks

For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormonal implants) or abstinence must be used throughout the study period and for 28 days after their final vaccine administration (a barrier method of contraception must be employed by all subjects [male and female], regardless of other methods unless abstinent). A negative serum or urine pregnancy test is required as part of screening. Women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/ml

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Exclusion Criteria

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.

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Participant Groups

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.

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.