Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21
- Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant
QS21 in patients with prostate cancer.
- Determine the antibody response in patients treated with this vaccination therapy.
- Assess post-immunization changes in PSA levels and other objective parameters of
disease (radionuclide bone scan) in patients treated with this vaccination therapy.
OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant
QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable
toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40
and who have no disease progression may receive a seventh vaccination after week 50.
Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Susan Slovin, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|