This trial is active, not recruiting.

Condition prostate cancer
Treatment autologous dendritic cell vaccine (dc/pc3)
Phase phase 1/phase 2
Sponsor Rockefeller University
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (dc/pc3)
ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukapheresate, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity

Primary Outcomes

time frame: throughout the study

Secondary Outcomes

time frame: Day 0, Week 3, 4, 5, 7, 9, 13, 17
Clinical Response
time frame: baseline, and at 5 weeks and 17 weeks after completion of

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Rockefeller University.