Clinical trial · Interventional
Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
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]
NCT00064103CI-TRIAL-00009035completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lip and Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | ALIAS | 0.90 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Stage 0 Lip and Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.78 |
| Stage 0 Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_BROADER | 0.78 |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5CMV-p53 gene | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Ad5CMV-p53 gene)
- description
- 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 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.
- interventionNames
- Biological: Ad5CMV-p53 gene
- Other: laboratory biomarker analysis
Primary outcomes (4)
- measure
- Frequency of adverse events
- timeFrame
- Up to 15 years
- measure
- Severity of adverse events graded using the CTCAE version 3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/dayReferences
Publications (0)
Data not yet available
No reference posted for this study.