NCT00108264

Brief Summary

The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 21, 2009

Status Verified

May 1, 2007

First QC Date

April 14, 2005

Last Update Submit

January 20, 2009

Conditions

Prostate Cancer

Keywords

Prostatic NeoplasmsNeoplasm MetastasisImmunotherapyActiveDendritic Cells

Interventions

Tumor RNA transfected dendritic cellsBIOLOGICAL

Eligibility Criteria

Age10 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histologically confirmed diagnosis of metastatic prostate cancer stages D1 - D3 are eligible for this study.
  • They must not have a history of autoimmune disease, serious intercurrent chronic or acute illness, pulmonary disease, active hepatitis, serologic evidence for HIV, or be receiving corticosteroid or immunosuppressive therapy.

You may not qualify if:

  • Patients will be excluded from the study if they have received chemotherapy or other forms of immunotherapy in the 6 weeks prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm MetastasisMotor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Completion

September 1, 2005

Last Updated

January 21, 2009

Record last verified: 2007-05

Locations

US(1)