Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00003257
- Lead Sponsor
- Aventis Pharmaceuticals
- Brief Summary
RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have recurrent head and neck cancer.
- Detailed Description
OBJECTIVES: I. Estimate the objective response rate of Ad5CMV-p53 in patients with recurrent squamous cell carcinoma of the head and neck. II. Evaluate the duration of response, time to disease progression, and overall survival of these patients after this treatment. III. Evaluate the effectiveness of Ad5CMV-p53 in reducing cancer morbidity (pain assessment, analgesic consumption, and Karnofsky performance status). IV. Assess the quality of life of these patients receiving this treatment.
OUTLINE: This is a multicenter, open label study. All patients receive direct intratumoral injections of Ad5CMV-p53 on days 1, 2, and 3 of each 4-week treatment course. Patients are treated for at least 2 courses barring local disease progression or unacceptable adverse events; patients with responding or stable disease receive a maximum of 12 courses. Patients are evaluated for safety 4 weeks from the completion of the last treatment. Quality of life is assessed before, during, and after treatment. Patients are followed every 2 months for up to 18 months or until death.
PROJECTED ACCRUAL: A maximum of 39 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Sidney Kimmel Cancer Center
πΊπΈSan Diego, California, United States
University of Colorado Cancer Center
πΊπΈDenver, Colorado, United States
University of Connecticut School of Medicine
πΊπΈFarmington, Connecticut, United States
Clinical Sciences Building
πΊπΈChicago, Illinois, United States
University of Iowa Hospitals and Clinics
πΊπΈIowa City, Iowa, United States
University of Kansas Medical Center
πΊπΈKansas City, Kansas, United States
Tulane University School of Medicine
πΊπΈNew Orleans, Louisiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
πΊπΈBaltimore, Maryland, United States
Albert Einstein Comprehensive Cancer Center
πΊπΈBronx, New York, United States
Simmons Cancer Center - Dallas
πΊπΈDallas, Texas, United States
Sidney Kimmel Cancer CenterπΊπΈSan Diego, California, United States