Wild Type p53 Adenovirus for Oral Premalignancies
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|