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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) Department of Health and Human Services |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00410865 |
Primary Objectives:
Condition | Intervention | Phase |
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Mouth Cancer |
Genetic: INGN 201 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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] |
Estimated Enrollment: | 51 |
Study Start Date: | June 2003 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
INGN 201
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Gary L. Clayman, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Gary L. Clayman, MD/Professor ) |
Study ID Numbers: | ID00-193 |
Study First Received: | December 11, 2006 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00410865 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Oral Premalignancies Mouth Cancer Dysplasia/Carcinoma in Situ (CIS) of the Oral Cavity Dysplasia/Carcinoma in situ (CIS) of the Oral Pharynx |
Advexin Gene Therapy INGN 201 Wild Type p53 Gene Induction |
Mouth Diseases Head and Neck Neoplasms Carcinoma in Situ Adenoviridae Infections |
Stomatognathic Diseases Mouth Neoplasms Oral Cancer Carcinoma |
Mouth Diseases Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Stomatognathic Diseases Mouth Neoplasms |