S0011, Gene Therapy & Surgery Followed by Chemo & RT in Newly Diagnosed Cancer of the Mouth or Throat
- Conditions
- Head and Neck Cancer
- Interventions
- Biological: Ad5CMV-p53 geneProcedure: conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT00017173
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by cisplatin and radiation therapy in treating patients who have newly diagnosed resectable stage III or stage IV cancer of the mouth or throat.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description surgery with INGN 201 followed by chemo/RT Ad5CMV-p53 gene intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy surgery with INGN 201 followed by chemo/RT cisplatin intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy surgery with INGN 201 followed by chemo/RT conventional surgery intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy surgery with INGN 201 followed by chemo/RT radiation therapy intraoperative and postoperative injections of INGN 201 into the tumor bed, followed by cisplatin and radiation therapy
- Primary Outcome Measures
Name Time Method Feasibility 1 year accrual rate and percentage of patients successfully receiving the required doses of INGN 201
- Secondary Outcome Measures
Name Time Method Progression-free survival from time of registration until disease progression two years percentage of patient who have not experience progression of disease at two years
Trial Locations
- Locations (3)
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States