Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.
|ClinicalTrials.gov Identifier: NCT00289341|
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : January 8, 2013
Last Update Posted : January 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: vaccine vehicle only Biological: DC/LNCaP||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/LNCaP) Administered Subcutaneously to Prostate Cancer Patients.|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Placebo Comparator: Placebo
12 patients in the placebo Arm for 8 weeks followed by DC/LNCAP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks.
Biological: vaccine vehicle only
Subcutaneous injection of vaccine vehicle only (5% DMSO in normal saline), followed by cross-over to Arm 1 design.
12 patients, receiving DC/LNCaP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks
Subcutaneous injection of DC/LNCaP, DC/LNCaP-M1, DC/KLH
- Adverse Event [ Time Frame: End of blinded phase (wk 9) ]Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.
- Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group. [ Time Frame: pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13 ]The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.
- Change in PSA Slope, Pre- vs Post-vaccination. [ Time Frame: pre- vs post- vaccination PSA slopes. ]To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used. Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase. To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model. For the general model, random effects for the intercept, slope and the first knot were considered.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289341
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Robert B. Darnell, MD, PHD||Rockefeller University|