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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Study of Oral and Intramucosal Ad5CMV-p53 Gene in Patients With Diffuse Premalignant Carcinoma of the Oral Cavity or Oral Pharynx

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Prevention Completed 18 and over NCI MDA-ID-00193 NCI-6053, NCT00064103, 6053

Trial Description

Purpose:

Inserting the p53 gene into a person's tumor cells may improve the body's ability to kill the tumor cells.

This phase I/II trial is studying the side effects and best dose of gene therapy and to see how well it works in preventing cancer in patients with premalignant carcinoma of the oral cavity or pharynx.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• More than 3 weeks since chemotherapy
• More than 3 months since radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an injection of the p53 gene into the tumor. At least 2 hours later, they will receive the p53 gene in a mouth rinse. Patients will then use the mouth rinse twice a day for 4 days. Treatment may be repeated every 4 weeks for six courses. Patients will be evaluated every 3 months for 1 year, every 6 months for 1 year, and once a year for 13 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Gary L. Clayman, MD, DDS, Protocol chair		Ph: 713-792-6525; 800-392-1611 Email: gclayman@mdanderson.org
Scott Lippman, MD, FACP, Protocol co-chair		Ph: 713-745-5439; 800-392-1611

Registry Information
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]
Trial Start Date		2006-06-25
Registered in ClinicalTrials.gov		NCT00064103
Date Submitted to PDQ		2003-05-20
Information Last Verified		2007-01-25
NCI Grant/Contract Number		CA97007, CA16672

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