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Home > "G" Clinical Trials Conditions > Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx  Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
For Condition: lip and oral cavity cancer,stage 0 lip and oral cavity cancer,Oropharyngeal Cancer,stage 0 oropharyngeal cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Inserting the p53 gene into a person's tumor cells may improve the body's ability to kill the tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of gene therapy in preventing cancer in patients who have premalignantcarcinoma of the oral cavity or pharynx.
Details: OBJECTIVES: - 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. - Determine the maximum tolerated dose of this drug in these patients. - Determine the topical transduction efficiency of adenoviral-mediated wild type p53 gene transfer in patients treated with this drug. - Determine the efficacy of this drug in reversing the histology of oral premalignancies in these patients. - 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. - 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. PROJECTED ACCRUAL: A total of 18-51 patients (18 for phase I and 33 for phase II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.0 mg/dL Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No hypertension (baseline blood pressure 140/90 or higher) Other - 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 - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - More than 21 days since prior chemotherapy (42 days for mitomycin and nitrosoureas) - No concurrent systemic chemotherapy Endocrine therapy - No concurrent prednisone or the equivalent, including corticosteroids of more than 10 mg/day Radiotherapy - See Disease Characteristics - More than 3 months since prior radiotherapy involving the lesion selected for this study - No concurrent radiotherapy Surgery - See Disease Characteristics Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GaryClayman, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Gary Clayman 713-792-6525
Additional Information:
Study ID Numbers: CDR0000306522; MDA-ID-00193,NCI-6053
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064103
Other Lip And Oral Cavity Cancer Studies:
1. BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
2. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
3. Bortezomib Followed by the Addition of Doxorubicin at Disease Progression in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma (Cancer) of the Head and Neck
4. ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
5. Radiation Therapy With or Without Epoetin alfa in Anemic Patients With Head and Neck Cancer
Related Studies:
Other lip and oral cavity cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Gene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
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