Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase I/II Study of Autologous Dendrtitic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00345293
• Other study ID #: RDA-0537
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 26, 2006
• Last updated: March 17, 2015
• Start date: June 2006
• Est. completion date: June 2015

Study information

• Verified date: September 2013
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See Brief Summary.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		throughout the study	Yes
Secondary	Immunogenicity		Day 0, Week 3, 4, 5, 7, 9, 13, 17	No
Secondary	Clinical Response		baseline, and at 5 weeks and 17 weeks after completion of	No

External Links

•   study description at Rockefeller University website