MUC1 Vaccine in Conjunction With Poly-ICLC in Patients With Recurrent and/or Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of a drug called Poly-ICLC, also known as HiltonolTM, in boosting the body's immune system's response to an experimental vaccine therapy (called the MUC-1 vaccine).

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00374049
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 1
• Start date: June 2006
• Completion date: December 2015