Phase II Trial Of Surgery With Perioperative RPR/INGN 201 (Ad5CMV-p53) Gene Therapy Followed By Chemoradiotherapy For Advanced, Resectable Squamous Cell Carcinoma Of The Oral Cavity, Oropharynx, Larynx, and Pharynx
- Determine the feasibility of treating patients with newly diagnosed resectable stage
III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or
larynx with surgery and Ad5CMV-p53 gene followed by cisplatin and radiotherapy.
- Determine the progression-free survival, local control, and overall survival of
patients treated with this regimen.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo surgical resection and receive an intraoperative Ad5CMV-p53 gene injection
into the resection bed and into the deep soft tissue bed of the cervical level with nodal
metastasis. Patients also receive a third intraoperative Ad5CMV-p53 gene injection into the
neck dissection bed, where it is allowed to sit in place for 10 minutes.
Within 48-72 hours after surgery, patients receive a postoperative Ad5CMV-p53 gene injection
into each of two drainage catheters next to the mucosal suture line and neck dissection bed,
where it is allowed to sit in place for 2 hours.
Within 56 days after surgery, patients receive cisplatin IV over 30-90 minutes on days 1,
22, and 43 and radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients may
receive 3 additional days of radiotherapy to high-risk areas on days 43-45.
Patients are followed every 2-6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
accrual rate and percentage of patients successfully receiving the required doses of INGN 201
George H. Yoo, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Markey Cancer Center at University of Kentucky Chandler Medical Center||Lexington, Kentucky 40536-0084|