Vaccination of Prostate Cancer Patients With Thompson-Friedenreich [TF(c)]-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing TF(c)-KLH Doses
OBJECTIVES: I. Determine the optimal dose of Thompson-Friedenreich [TF(c)]-keyhole limpet
hemocyanin (KLH) conjugate plus adjuvant QS21 that induces an antibody response in patients
with prostate cancer. II. Determine the safety of the TF(c)-KLH conjugate prepared using an
MBS heterobifunctional linker plus QS21. III. Assess postimmunization changes in prostate
specific antigen levels and other objective parameters of disease in these patients.
OUTLINE: This is a dose escalation study. Patients receive TF(c)-KLH conjugate with adjuvant
QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5
patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on
antibody response, is reached. Patients are followed monthly for 6 months, then every 3
months for 1 year.
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|