Biological Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00039299|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: therapeutic autologous lymphocytes||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer|
|Study Start Date :||March 2002|
|Study Completion Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039299
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1738|
|Study Chair:||Allan Pantuck, MD||Jonsson Comprehensive Cancer Center|