A Pilot Multivalent Conjugate Vaccine Trial for Patients With Biochemically Relapsed Prostate Cancer
This is a pilot trial designed to assess safety and immunogenicity of a multivalent
conjugate vaccine for use in patients with biochemically relapsed prostate cancer. This
trial is based on the results of eight dose-seeking phase I monovalent glycoprotein and
carbohydrate conjugate vaccine trials in a patient population with minimal tumor burden
despite a rising biomarker, PSA, who have failed primary therapy such as surgery or
radiation. We know that a rising PSA is indicative of micrometastatic disease - a state to
which the immune system may maximally respond. Based on these trials, we have identified
three glycolipid antigens, Globo H, Lewisy and GM2 and three mucin antigens, glycosylated
MUC-1, Tn(c), and TF(c) for inclusion into a multivalent trial. As a result of these
vaccinations, most patients generated specific high titer IgM and IgG antibodies against the
respective antigen-KLH conjugates. Our previous work has shown the monovalent vaccines to
be safe with local erythema and edema but minimal systemic toxicities. Our data from
approximately 160 men who participated in our earlier monovalent vaccine trials against the
aforementioned antigens have shown that a treatment effect in the form of a decline in PSA
log slopes compared with pretreatment values could be seen in patients with minimal tumor
burden. The multivalent vaccine will consist of the lowest dose of synthetic glycoprotein
and carbohydrate antigens shown to elicit high titer IgM and IgG antibodies in patients with
biochemically relapsed prostate cancer. A phase III double blind randomized trial with two
hundred forty patients is planned based on the safety and immunogenicity data accrued from
this pilot trial.
The primary endpoints of this study will be the safety of the vaccine and the humoral
response to each of the antigens. The secondary endpoint will be to evaluate post-therapy
changes in PSA.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall antitumor assessment performed during weeks 19 and 31. If no progression of disease continue on protocol. After week 31, will be monitored every 3 months with history, physical, performance status and bloodwork. Imaging studies every 6 mo.
11/2000-12/2008
Yes
Susan Slovin, MD, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
00-064
NCT00579423
November 2000
March 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |