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 ...

Summary

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.

Timeline

Start

2009-03-13

Primary completion

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Completion

2012-08-02

Publications

• Background Robbins PF, Eggensperger D, Qi CF, Schlom J. Definition of the expression of the human carcinoembryonic antigen and non-specific cross-reacting antigen in human breast and lung carcinomas. Int J Cancer. 1993 Apr 1;53(6):892-7. doi: 10.1002/ijc.2910530604.
• Background Kass ES, Greiner JW, Kantor JA, Tsang KY, Guadagni F, Chen Z, Clark B, De Pascalis R, Schlom J, Van Waes C. Carcinoembryonic antigen as a target for specific antitumor immunotherapy of head and neck cancer. Cancer Res. 2002 Sep 1;62(17):5049-57.
• Background Hodge JW, Tsang KY, Poole DJ, Schlom J. General keynote: vaccine strategies for the therapy of ovarian cancer. Gynecol Oncol. 2003 Jan;88(1 Pt 2):S97-104; discussion S110-3. doi: 10.1006/gyno.2002.6694. No abstract available.

Drugs

Indications