Clinical Trials Logo
  1. Home
  2. Oropharyngeal Cancer
  3. NCT00064103

Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx

Oropharyngeal Cancer Clinical Trial

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]

Clinical Trial Summary

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

Clinical Trial Description

OBJECTIVES:

I. Determine the acute toxic effects of Ad5CMV-p53 gene administered as an oral rinse and as an intramucosal injection in patients with diffuse premalignant carcinoma of the oral cavity or oral pharynx.

II. Determine the maximum tolerated dose of this drug in these patients. III. Determine the topical transduction efficiency of adenoviral-mediated wild type p53 gene transfer in patients treated with this drug.

IV. Determine the efficacy of this drug in reversing the histology of oral premalignancies in these patients.

V. Determine the distribution of transgenic protein within the area of the premalignant lesion in patients treated with this drug.

OUTLINE: This is an open-label, dose-escalation study of Ad5CMV-p53 gene administered as an oral rinse.

Phase I: Patients receive Ad5CMV-p53 gene by intramucosal injection into the area of the lesion followed at least 2 hours later by Ad5CMV-p53 gene as an oral rinse on day 1. Patients then receive Ad5CMV-p53 gene as an oral rinse twice daily on days 2-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of Ad5CMV-p53 gene as an oral rinse until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive treatment with intramucosal Ad5CMV-p53 gene as in phase I and Ad5CMV-p53 gene as an oral rinse at the MTD. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. Patients then receive long-term follow-up annually for an additional 10 years. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00064103
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 2003
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03656133 - Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers N/A
Terminated NCT02225496 - Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma Phase 2
Withdrawn NCT01767961 - Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer N/A
Completed NCT01695122 - Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT01435252 - A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab Phase 2
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Withdrawn NCT00951470 - Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema N/A
Completed NCT01358097 - Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy N/A
Completed NCT01342978 - Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time N/A
Completed NCT00964977 - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis. Phase 3
Recruiting NCT05363709 - BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients Phase 2
Completed NCT02280811 - T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers Phase 2
Active, not recruiting NCT03777384 - EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT06121102 - Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain N/A
Recruiting NCT02984410 - Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma N/A
Recruiting NCT02960724 - uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer Phase 2
Completed NCT02934724 - Impact of HPV Vaccine On The Prevalence Of HPV In Norway
Withdrawn NCT00928161 - Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy N/A
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research