Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21
- Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and
QS21 immunoadjuvant in patients with metastatic breast cancer.
- Determine the IgG and IgM antibody response to this regimen in these patients.
- Determine the proportion of breast cancer cells expressing this antigen in these
- Monitor the presence of circulating tumor cells prior to, during, and after this
regimen in these patients.
OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine
subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the
absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and
reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot
After completion of study treatment, patients are followed every 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Teresa Ann Gilewski, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|