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

Completed · Phase 1/Phase 2

Conditions studied: Lip and Oral Cavity Cancer, Oropharyngeal Cancer, Stage 0 Lip and Oral Cavity Cancer, Stage 0 Oropharyngeal Cancer, Tongue Cancer

In brief

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

Key facts

Study ID: NCT00064103
Run by: National Cancer Institute (NCI)
People needed: 51
Starts: 2003-06-01
Last updated by the study team: 2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed mild to moderate dysplasia OR severe dysplasia/carcinoma in situ of the oral cavity or oral pharynx
Clinically evident diffuse premalignant disease, defined by 1 of the following mucosal abnormalities:
Extension between adjacent organ structures (e.g., lateral tongue, ventral tongue, and the floor of the mouth)
Extensive surface area, including the entire ventral tongue or floor of the mouth or buccal mucosa, in a velvety "indiscreet" pattern
Meets 1 of the following criteria:
Previously treated with conventional treatment (e.g., radiotherapy or surgery) for a prior head and neck malignancy
Failed biochemoprevention approaches for premalignant disease
Failed other therapeutic approaches for premalignant disease
No active squamous cell carcinoma of the head and neck
Performance status - Karnofsky 70-100%
Absolute granulocyte count at least 2,000/mm\^3
Platelet count at least 100,000/mm\^3
Bilirubin no greater than 1.0 mg/dL
Creatinine no greater than 1.5 mg/dL
No hypertension (baseline blood pressure 140/90 mm Hg or higher)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 1 year after study participation
HIV-1 negative
No known contact with former tissue or organ transplantation recipients or individuals with severe immunodeficiency disease (acquired or congenital) during and for 28 days after study treatment
No prior malignancy within the past 2 years except nonmelanoma skin cancer or aerodigestive cancer
No active systemic viral, bacterial, or fungal infections requiring treatment
No serious concurrent illness that would preclude study compliance and follow-up
No psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up
See Disease Characteristics

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.