NCT01171729

Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

A Phase I/IIa Study of Autologous Cell-based Vaccine Therapy With CreaVax-PC in Hormone-Refractory Metastatic Prostate Cancer Patients With PSA Relapse to Evaluate the Safety and Efficacy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.

Detailed description

CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens. If patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (CreaVax-PC). In detail, patients will receive CreaVax-PC injection at intervals of 3 weeks, maximum 6 times during 21 weeks. PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. We also evaluate time to progression, overall survival and immune response.

Conditions

• Prostatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Autologous dendritic cell	Autologous dendritic cells pulsed with prostate cancer antigen and KLH

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-07-28
• Last updated: 2010-08-11

Locations

2 sites across 1 country: South Korea