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Neoadjuvant Study of In-situ REIC/Dkk-3 in Prostate Cancer

NCT01197209 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-08-23

No results posted yet for this study

Summary

This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label, dose-escalation trial for prostate cancer patients with high risk of local recurrence after radical prostatectomy. Patients entered into this trial will have Prostate Cancer of Clinical stage T1c, T2 or T3 with a Gleason Score of between 7 (4+3) and 10 at the time of enrollment. Patients will receive three 1 mL injections (3 mL total volume) of Ad-REIC/Dkk-3 into the prostate prior to undergoing a radical prostatectomy. Three patients will be treated at each dose level unless a dose-limiting toxicity (DLT) is observed or MFD (defined as 1 x 10e12 vp/treatment) is achieved with expansion for up to 6 more patients at the MTD or MFD.

Conditions

Interventions

BIOLOGICAL

Ad-REIC/Dkk-3

REIC (Reduced Expression in Immortalized Cells) protein is down regulated in a variety of cancer cell lines including prostate tumors. The REIC gene is identical to the Dickkopf-3 (Dkk-3) gene that is a member of the Dickkopf gene family. Ad-REIC/Dkk-3 is designed as a viral vector that delivers a DNA plasmid capable of producing intracellular REIC protein. The expression plasmid includes the full-length human cDNA sequence for REIC. The adenovirus vector is a transport mechanism to infuse the REIC/Dkk-3 plasmid into the cell providing a temporary transfusion of REIC protein.

Sponsors & Collaborators

Principal Investigators

  • Simon Hall, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01197209 on ClinicalTrials.gov