Back to resultsDendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
autologous dendritic cell vaccine (DC/PC3)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Rockefeller University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DC/PC3 vaccine
Arm Description
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)
Outcomes
Primary Outcome Measures
Toxicity
adverse events
Secondary Outcome Measures
Immunogenicity
The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).
Clinical Response
Full Information
NCT ID
NCT00345293
First Posted
June 26, 2006
Last Updated
April 1, 2016
Sponsor
Rockefeller University
Collaborators
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00345293
Brief Title
Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
Official Title
A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University
Collaborators
Memorial Sloan Kettering Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
See Brief Summary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DC/PC3 vaccine
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
autologous dendritic cell vaccine (DC/PC3)
Intervention Description
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 leukaphereses product, 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 Outcome Measure Information:
Title
Toxicity
Description
adverse events
Time Frame
through week 29
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).
Time Frame
pre and post treatment
Title
Clinical Response
Time Frame
Post treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Darnell, MD PHD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25475068
Citation
Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.
Results Reference
derived
Learn more about this trial
Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
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