A Pilot Dose Finding Study of MUC1 Vaccine in Conjunction With Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) or HiltonolTM in Patients With Recurrent and/or Advanced Prostate Cancer
This is a one-arm clinical trial, to evaluate 2 doses of poly-ICLC for reversing systemic
immuno-suppression: 25 μg/kg and 50 μg/kg. These doses will be administered I.M. three
times a week for 2 weeks. Following 2 weeks of treatment with poly-ICLC alone, patients
will be immunized subcutaneously with the 100-mer MUC-1 peptide + GM-CSF. Subjects will be
boosted twice at two week intervals, and subsequently 3 months later, if they experience
clinical benefit or if they have clinically stable disease. Poly-ICLC will be administered
continually 3 times a week I.M. for the first 2 weeks and 2 times a week I.M. thereafter.
Subjects will continue on study until they have evidence of progressive disease. The primary
objective of this study is to evaluate the efficacy of Poly-ICLC in boosting the immunologic
response of a MUC1 vaccine. Secondary objectives are to evaluate a) changes in markers of
systemic immunosuppression; b) changes in dendritic cell number and function; and c)
clinical response. Up to 30 subjects will be enrolled in this single-site study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients showing an immunologic response at week 8
8weeks
Yes
Leonard J Appleman, MD
Principal Investigator
University of Pittsburgh
United States: Food and Drug Administration
05-086
NCT00374049
June 2006
July 2013
Name | Location |
---|---|
Hillman Cancer Center | Pittsburg, Pennsylvania 15232 |