Immunization of Metastatic Breast Cancer Patients with a Fully Synthetic Globo H Conjugate: A Phase I Trial

The carbohydrate antigen globo H commonly found on breast cancer cells is a potential target for vaccine therapy. The objectives of this trial were to determine the toxicity and immunogenicity of three synthetic globo H-keyhole limpet hemocyanin conjugates plus the immunologic adjuvant QS-21. Twenty...

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Bibliographic Details
Published in:Proceedings of the National Academy of Sciences - PNAS 2001-03, Vol.98 (6), p.3270-3275
Main Authors: Gilewski, Teresa, Ragupathi, Govindaswami, Bhuta, Sonal, Williams, Lawrence J., Musselli, Cristina, Zhang, Xu-Fang, Bencsath, Kalman P., Panageas, Katherine S., Chin, Jeanette, Hudis, Clifford A., Norton, Larry, Houghton, Alan N., Livingston, Philip O., Danishefsky, Samuel J.
Format: Article
Language:English
Subjects:
Adult
Antibodies
Antigens
Biological Sciences
Bone Neoplasms - secondary
Bone Neoplasms - therapy
Breast cancer
Breast Neoplasms - therapy
Cancer Vaccines - adverse effects
Cancer Vaccines - immunology
Cancer Vaccines - therapeutic use
Carbohydrate Sequence
carbohydrates
Disease progression
Enzyme linked immunosorbent assay
Female
Grade 3
Humans
Immunization
Immunology
Liver Neoplasms - secondary
Liver Neoplasms - therapy
Lung Neoplasms - secondary
Lung Neoplasms - therapy
Lymphatic Metastasis
Middle Aged
Molecular Sequence Data
Neoplasm Metastasis
Pretreatment
Reactivity
Treatment Outcome
Tumors
Vaccination
Vaccines
Vaccines, Conjugate - adverse effects
Vaccines, Conjugate - immunology
Vaccines, Conjugate - therapeutic use
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Summary:The carbohydrate antigen globo H commonly found on breast cancer cells is a potential target for vaccine therapy. The objectives of this trial were to determine the toxicity and immunogenicity of three synthetic globo H-keyhole limpet hemocyanin conjugates plus the immunologic adjuvant QS-21. Twenty-seven metastatic breast cancer patients received five vaccinations each. The vaccine was well tolerated, and no definite differences were observed among the three formulations. Serologic analyses demonstrated the generation of IgM antibody titers in most patients, with minimal IgG antibody stimulation. There was significant binding of IgM antibodies to MCF-7 tumor cells in 16 patients, whereas IgG antibody reactivity was observed in a few patients. There was evidence of complement-dependent cytotoxicity in several patients. Affinity column purification supported the specificity of IgM antibodies for globo H. On the basis of these data, globo H will constitute one component of a polyvalent vaccine for evaluation in high-risk breast cancer patients.
ISSN:0027-8424
1091-6490
DOI:10.1073/pnas.051626298