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Wild Type p53 Adenovirus for Oral Premalignancies

NCT00410865 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2011-12-07

No results posted yet for this study

Summary

Primary Objectives:

1. To determine the maximum tolerated dose and transduction efficiency of adenoviral mediated wild type p53 gene transfer in premalignancies of the upper aerodigestive tract.
2. To determine the efficacy of single agent adenoviral mediated wild type p53 gene transfer in reversing oral premalignancies.

Conditions

  • Mouth Cancer

Interventions

GENETIC

INGN 201

Mouth rinse given one time on the first day and two times on Days 2-5 of each course of INGN 201. The injection and rinse (first day of each cycle), or the two rinses (Days 2-5 of each cycle), will be separated by at least two hours.

Sponsors & Collaborators

Principal Investigators

  • Gary L. Clayman, MD · U.T. MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2008-03-31
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

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 NCT00410865 on ClinicalTrials.gov