Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Robert Darnell
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Robert Darnell, Rockefeller University
ClinicalTrials.gov Identifier:
NCT00345293
First received: June 26, 2006
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: autologous dendritic cell vaccine (DC/PC3) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Autologous Dendrtitic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients. |
Resource links provided by NLM:
Further study details as provided by Rockefeller University:
Primary Outcome Measures:
- Toxicity [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immunogenicity [ Time Frame: Day 0, Week 3, 4, 5, 7, 9, 13, 17 ] [ Designated as safety issue: No ]
- Clinical Response [ Time Frame: baseline, and at 5 weeks and 17 weeks after completion of ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DC/PC3 vaccine
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)
|
Biological: 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Prostate cancer
Rising PSA (3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) HLA-A2.1
-
Exclusion Criteria:
CNS metastasis
History of autoimmune disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345293
Locations
| United States, New York | |
| Rockefeller University Hospital | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Robert Darnell
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Robert B Darnell, MD PHD | Rockefeller University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert Darnell, Head, Laboratory of Molecular Neuro-Oncology, Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00345293 History of Changes |
| Other Study ID Numbers: | RDA-0537 |
| Study First Received: | June 26, 2006 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Rockefeller University:
|
Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 13, 2013