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Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer

NCT00753220 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-11-04

Study results available
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Summary

The purpose of this study is to determine if the intra-tumoral injection of a subject's own dendritic cells after cryotherapy of the prostate is a safe and effective treatment for advanced prostate cancer.

In theory, the injected dendritic cells will internalize antigens from the tumor cells which have been damaged by cryotherapy and activate the subject's immune system against that specific tumor.

Subjects will also receive a low dose chemotherapy designed to lower the number of T-regulatory cells which have been shown to lower or stop some immune system responses.

Hypothesis 1: Dendritic cell injection into cryotreated prostate cancer is non-toxic;

Hypothesis 2: Dendritic cell injection into cryotreated prostate cancer is medically beneficial to the subject.

Conditions

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide i.v. given at day -3 (dose: 300mg/m2); Low-dose Cyclophosphamide pill given twice daily (dose: 25 mg, p.o., b.i.d. for 7 days on and 7 days off; a total of 6 cycles \[1 cycle = 4 weeks\] starting Week 2 after cryoablation and going to Week 26)

BIOLOGICAL

VDC2008

Intratumoral injection of VDC2008 post-cryotherapy. Dosage will depend on cohort: 2.5 x 10\^7, 7.5 x 10\^7 or 1.0 x 10\^8 cells

Sponsors & Collaborators

  • Prostate Institute of America

    collaborator UNKNOWN

  • Community Memorial HealthCenter

    collaborator OTHER

  • HemaCare Corporation

    collaborator UNKNOWN

  • Bostwick Laboratories

    lead INDUSTRY

Principal Investigators

  • Duke K Bahn, M.D. · Prostate Institue of America

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-05-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00753220 on ClinicalTrials.gov