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This study investigated whether Ad5CMV-p53 gene therapy could prevent cancer developing in patients with premalignant lesions of the oral cavity or pharynx. Patients with mild to moderate dysplasia, or severe dysplasia/carcinoma in situ with widespread mucosal disease, took part. It was carried out as a Phase 1/2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
* 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
* More than 21 days since prior chemotherapy (42 days for mitomycin and nitrosoureas)
* No concurrent systemic chemotherapy
* No concurrent prednisone or the equivalent, including corticosteroids of more than 10 mg/day
* See Disease Characteristics
* More than 3 months since prior radiotherapy involving the lesion selected for this study
* No concurrent radiotherapy
* See Disease Characteristics
* More than 8 weeks since prior investigational agents
* No prior experimental therapy (i.e., oral, systemic, topical, or direct injection) for the lesion selected for treatment in this study
* No other concurrent immunosuppressive therapy
* No other concurrent investigational agents
* No concurrent aspirin dose greater than 175 mg/day