Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017173
Status:
TERMINATED
Last Update Posted:
2012-06-14
First Post:
2001-06-06
Brief Title:
S0011 Gene Therapy Surgery Followed by Chemo RT in Newly Diagnosed Cancer of the Mouth or Throat
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial Of Surgery With Perioperative RPRINGN 201 Ad5CMV-p53 Gene Therapy Followed By Chemoradiotherapy For Advanced Resectable Squamous Cell Carcinoma Of The Oral Cavity Oropharynx Larynx and Pharynx
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated for poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Inserting the p53 gene into a persons cancer cells may improve the bodys 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0011 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |