An Open Label Phase I Study to Eval the Safety and Tolerability of a Vaccine (GI-6207) Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-expressing ...

Completed · Phase 1

Conditions studied: Prostate Cancer, Breast Cancer, Lung Cancer, Colorectal Cancer, Head and Neck Cancer

In brief

Objectives: * To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects. * To see if GI-6207 has any effect on patients tumors. * To learn how the vaccine causes immune responses against the cancer. Eligibility: * Patients 18 years of age and older who have been diagnosed with a cancer that has not responded to standard treatments. Patients must not be allergic to yeast or yeast products. Design: * Initial physical examination, blood and tissue sampling, computed tomography (CT) scan, and skin test to determine eligibility for the procedure. * Treatment with GI-6027 in seven 14-day cycles as follows: * Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85. * Vaccine given at four sites around the body: right and left chest area below the armpit, and right and left upper thigh in the pelvic region. (These areas drain into parts of your body that contain large numbers of lymph nodes. The lymph nodes contain immune cells that may be activated by the vaccine to target cancer cells.) * Clinic visits for physical examinations to check vital signs, take additional blood and urine samples, and perform other tests needed for the study. * After day 85 (about 3 months), patients will continue to receive vaccine monthly (or every 28 days) as long as the vaccine is not producing harmful effects or side effects and the cancer is either stable or reducing. Patients who do well on the vaccine may continue to receive it for as long as it is available.

Key facts

Study ID

NCT00924092

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2009-03-13

Expected to finish

2012-08-02

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A. Patients should have no evidence of immune dysfunction as listed below.
• Human immunodeficiency virus positivity due to the potential for decreased immune response to the vaccine.
• Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. Patients with endocrine autoimmune disease that is controlled by replacement therapy, including thyroid disease and adrenal disease; or those with vitiligo, may be enrolled.
• Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids to prevent IV contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed.
• B. History of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded).
• C. Pregnant or breast-feeding women.
• E. Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
• F. Untreated brain metastases (or local treatment of brain metastases within the last 6 months) due to the poor prognosis of these patients and difficulty ascertaining the cause of neurologic toxicities.
• G. Concurrent chemotherapy. An exception is to allow for patients on the extension phase only with breast cancer who are receiving trastuzumab to continue therapy with trastuzumab while receiving the vaccine treatment.
• K. Chronic hepatitis infection, including B and C, because of potential immune impairment.
• L. Patients requiring continuous tricyclic antidepressant therapy should be excluded due to the interference with the yeast skin test in creating false negative test results.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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