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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
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.
OBJECTIVES: * 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 disease progression. 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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
July 1, 2000
Primary Completion Date
March 1, 2009
Completion Date
March 1, 2009
Last Updated
March 19, 2013
34
ACTUAL participants
GPI-0100
BIOLOGICAL
MUC-2-Globo H-KLH conjugate vaccine
BIOLOGICAL
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
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