Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
This trial is active, not recruiting.
|Treatment||autologous dendritic cell vaccine (dc/pc3)|
|Phase||phase 1/phase 2|
|Collaborator||Memorial Sloan Kettering Cancer Center.|
|Start date||June 2006|
|End date||December 2013|
|Trial size||10 participants|
|Trial identifier||NCT00345293, RDA-0537|
The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: throughout the study
time frame: Day 0, Week 3, 4, 5, 7, 9, 13, 17
time frame: baseline, and at 5 weeks and 17 weeks after completion of
Male participants at least 18 years old.
Inclusion Criteria: Prostate cancer Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1) - Exclusion Criteria: central nervous system metastasis History of autoimmune disease
|Official title||A Phase I/II Study of Autologous Dendrtitic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.|
|Principal investigator||Robert B Darnell, MD PHD|
|Description||See Brief Summary.|
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