A Pilot Multivalent Conjugate Vaccine Trial For Patients With Biochemically Relapsed Prostate Cancer
OBJECTIVES:
- Determine the safety of a multivalent conjugate vaccine comprising Globo H, GM2,
Lewis-y, MUC-1-32-mer, TF(c), and Tn(c) antigens conjugated to keyhole limpet
hemocyanin (KLH) with adjuvant QS21 in patients with biochemically relapsed prostate
cancer.
- Measure the antibody response against the individual components of the vaccine and
correlate the response to subsequent clinical course in patients treated with this
vaccine.
- Assess post-immunization changes in prostate-specific antigen levels and other
objective parameters of the disease in these patients.
OUTLINE: Patients receive Globo H, MUC-1-32mer, GM2, Lewis-y, Tn(c), TF(c)-KLH conjugate
vaccine with adjuvant QS21 subcutaneously weekly on weeks 1, 2, 3, 7, 19, 31, 43, and 55.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 6 months.
Interventional
Primary Purpose: Treatment
Susan Slovin, MD, PhD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000068596
NCT00016120
June 2000
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |