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Phase I trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma

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Bilusic, Marijo, Heery, Christopher R., Arlen, Philip M., Rauckhorst, Myrna, Apelian, David, Tsang, Kwong Y., Tucker, Jo A., Jochems, Caroline, Schlom, Jeffrey, Gulley, James L., Madan, Ravi A.·2014·Cancer Immunology, Immunotherapy

DOI 10.1007/s00262-013-1505-8PMC PMC3944709

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Abstract

Yeast-CEA (GI-6207) is a therapeutic cancer vaccine genetically modified to express recombinant carcinoembryonic antigen (CEA) protein, using heat-killed yeast (Saccharomyces cerevisiae) as a vector. In preclinical studies, yeast-CEA induced a strong immune response to CEA and antitumor responses. Patients received subcutaneous vaccines every 2 weeks for 3 months and then monthly. Patients were enrolled at 3 sequential dose levels: 4, 16, and 40 yeast units (10(7) yeast particles/unit). Eligible patients were required to have serum CEA > 5 ng/mL or > 20 % CEA(+) tumor block, ECOG PS 0-2, and no history of autoimmunity. Restaging scans were performed at 3 months and then bimonthly. Peripheral blood was collected for the analysis of immune response (e.g., by ELISPOT assay). Twenty-five patients with metastatic CEA-expressing carcinomas were enrolled. Median patient age was 52 (range 39-81). A total of 135 vaccines were administered. The vaccine was well tolerated, and the most common adverse event was grade 1/2 injection-site reaction. Five patients had stable disease beyond 3 months (range 3.5-18 months), and each had CEA stabilization while on-study. Some patients showed evidence post-vaccination of increases in antigen-specific CD8(+) T cells and CD4(+) T lymphocytes and decreases in regulatory T cells. Of note, a patient with medullary thyroid cancer had substantial T cell responses and a vigorous inflammatory reaction at sites of metastatic disease. Yeast-CEA vaccination had minimal toxicity and induced some antigen-specific T cell responses and CEA stabilization in a heterogeneous, heavily pre-treated patient population. Further studies are required to determine the clinical benefit of yeast-CEA vaccination.

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Authors: Bilusic, M., Heery, C. R., Arlen, P. M., Rauckhorst, M., Apelian, D., Tsang, K. Y., Tucker, J. A., Jochems, C., Schlom, J., Gulley, J. L., & Madan, R. A.
Affiliations: National Institutes of Health (US)
GlobeImmune (United States) (US)
Corresponding author: Gulley, James L.
ORCID: Tucker, Jo A.
Schlom, Jeffrey
Gulley, James L.
Madan, Ravi A.
Venue: Cancer Immunology, Immunotherapy
Publisher: Springer Science and Business Media LLC
Published: 2013-12-07
Volume: 63
Issue: 3
Pages: 225-234
ISSN: 0340-7004 (ISSN-L)
1432-0851
DOI: 10.1007/s00262-013-1505-8
PMC: PMC3944709
OpenAlex: W2022660421
Cited by: 102
References: 44
Citations by year: 2026: 1 · 2025: 7 · 2024: 5 · 2023: 6 · 2022: 6 · 2021: 10 · 2020: 12 · 2019: 5 · 2018: 7 · 2017: 10 · 2016: 10 · 2015: 15 · 2014: 7
FWCI: 5.89
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.springer.com/tdm (tdm)
www.springer.com/tdm (vor)
Locations: Cancer Immunology Immunotherapy (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health
National Cancer Institute (Z01BC010666)
Topics: Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Life Sciences › Biochemistry, Genetics and Molecular Biology › Biotechnology › Bacterial Cancer Therapy
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Keywords: carcinoembryonic antigen, recombinant yeast vaccine, therapeutic cancer vaccines, metastatic carcinoma, medullary thyroid carcinoma, antigen-specific T cell responses, regulatory T cells, vaccine safety, dose escalation
MeSH terms: Adenocarcinoma, Adult, Aged, Aged, 80 and over, Carcinoembryonic Antigen, Cells, Cultured, Colonic Neoplasms, Female, Follow-Up Studies, Genetic Engineering, Genetic Vectors, Humans, Injections, Subcutaneous, Male, Middle Aged, Neoplasm Metastasis, Saccharomyces cerevisiae, CD4-Positive T-Lymphocytes, Cytokines, Treatment Outcome, CD8-Positive T-Lymphocytes, Vaccines, DNA, Cancer Vaccines, T-Lymphocytes, Regulatory, Enzyme-Linked Immunospot Assay

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Phase I trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma

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