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

NCT00365872 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-03-23

Study results available
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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.

Conditions

  • Soft Tissue Sarcoma

Interventions

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.

Sponsors & Collaborators

  • Cancer Treatment Research Foundation

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Scott Antonia, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365872 on ClinicalTrials.gov