Wild Type p53 Adenovirus for Oral Premalignancies
|ClinicalTrials.gov Identifier: NCT00410865|
Recruitment Status : Terminated (Sponsor withdrawl prior to study completion.)
First Posted : December 13, 2006
Last Update Posted : December 7, 2011
- To determine the maximum tolerated dose and transduction efficiency of adenoviral mediated wild type p53 gene transfer in premalignancies of the upper aerodigestive tract.
- To determine the efficacy of single agent adenoviral mediated wild type p53 gene transfer in reversing oral premalignancies.
|Condition or disease||Intervention/treatment||Phase|
|Mouth Cancer||Genetic: INGN 201||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Protocol for Wild Type p53 Gene Induction in Premalignancies of Squamous Epithelium of the Oral Cavity and Oral Pharynx Via an Adenoviral Vector [NCI Supplied Agent Ad-p53, (INGN 201) (Advexin®) NSC 683550, IND# 7135]|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||November 2010|
Experimental: INGN 201
INGN201 injection + oral rinse, day 1, courses 1-6. Twice-daily oral rinses, days 2-5, courses 1-6.
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.
- Maximum Tolerated Dose (MTD) of INGN 201 [ Time Frame: Following 1 week of experimental treatment in each 4 week course ]MTD is defined as the highest dose level at which there are less than or equal to 1/6 patients with a dose limiting toxicity (DLT).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410865
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gary L. Clayman, MD||U.T. MD Anderson Cancer Center|