Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050388
Status:
COMPLETED
Last Update Posted:
2008-06-24
First Post:
2002-12-06
Brief Title:
Phase II Trial of Allovectin-7 for Head and Neck Cancer
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
Phase II Study of the Safety and Efficacy of Allovectin-7 Immunotherapy for the Treatment of Primary Resectable Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to determine if Allovectin-7 an experimental gene-based immunotherapy can shrink head and neck tumors The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression
Detailed Description:
Treatment - If you take part in this trial you will be treated for about four weeks You will receive an injection of Allovectin-7 by needle directly into your tumor This will be repeated 14 days later The injections may be given in a doctors office A week later you will undergo surgery to remove the tumor Your tumor will be measured before Allovectin-7 treatment and before surgery to see if Allovectin-7 was effective in shrinking it This will be done by general physical exams and scans such as X-ray scans There will also be tests on the removed tumor to see if Allovectin-7 helped to boost the immune system to attack the cancer
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