NCT00365872

External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma

Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patient's 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 5,040 centigray (cGy) EBRT in 28 equal fractions. Radiation was delivered 5 days per week (Monday-Friday). DCs (10\^7 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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	Dendritic Cell (DC) Injections	* DCs (10\^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. * One additional DC injection was given before surgery to assess DC migration * Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery Group 2 - DC injection # 4 given 48 hours prior to surgery Group 3 - DC injection # 4 given 72 hours prior to surgery
PROCEDURE	Radiation therapy	Radiation was delivered 5 days per week (Monday-Friday).
PROCEDURE	Complete Resection - Surgery for tumor removal	Tumors were surgically resected 3-6 weeks after the completion of EBRT.

Timeline

• Start date: 2006-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-08-18
• Last updated: 2017-03-23
• Results posted: 2014-01-06

Locations

1 site across 1 country: United States