Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365872
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2006-08-17
Brief Title:
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells white blood cells as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma The purpose was to determine if an injection of the patients own immune related white blood cells into their tumor would strengthen the immune system to fight against their cancer
Detailed Description:
Patients were treated with external beam radiation therapy EBRT combined with experimental intratumoral injection of dendritic cell DC Patients received 5040 centigray cGy EBRT in 28 equal fractions Radiation was delivered 5 days per week Monday-Friday DCs 107 cells were injected intratumorally three times on the second third and fourth Friday during the course of radiation One additional DC injection was given several days before surgery to assess DC migration Tumors were surgically resected 3-6 weeks after the completion of EBRT
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