NCT00039299

Biological Therapy in Treating Patients With Prostate Cancer

A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: * Determine the safety of activated autologous T cells (Xcellerate) therapy in patients with hormone-refractory prostate cancer. * Determine the change in prostate-specific antigen (PSA) levels in patients treated with this therapy. * Determine the effects on bone in patients treated with this therapy. OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC). PBMC are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads (Xcellerate). Xcellerate-activated T cells are reinfused on day 0. Patients are followed weekly for 4 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic autologous lymphocytes

Timeline

• Start date: 2002-03-01
• Completion: 2003-06-01
• First posted: 2003-01-27
• Last updated: 2013-04-04

Locations

1 site across 1 country: United States