Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates: A Dose-Escalating Trial Studying The Immunogenicity And Safety Of The Immunological Adjuvant GPI-0100
- Determine the optimal (in terms of antibody response) and safe dose range of
glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 in patients
with biochemically relapsed prostate cancer.
- Assess post-immunization changes in prostate-specific antigen levels and other
objective parameters of disease in these patients.
OUTLINE: This is a dose-escalation study of GPI-0100.
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100
subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on
antibody response, is reached.
Patients are followed every 3 months.
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|