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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

Robert B Darnell, MD PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rockefeller University

Authority:

United States: Food and Drug Administration

Study ID:

RDA-0537

NCT ID:

NCT00345293

Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Rockefeller University HospitalNew York, New York  10021-6399