CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Dendritic Cell (DC) Injections +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00365872
NCT00365872Phase 2Completed
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Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Aug 18, 2006·Updated Mar 23, 2017

In Brief

A Phase 2 clinical trial evaluating Dendritic Cell (DC) Injections, Radiation therapy, and 1 other intervention for Soft Tissue Sarcoma. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma
CountriesUnited States
CollaboratorsCancer Treatment Research Foundation

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2006
Enrollment StartMay 1, 2006
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 19.9 years ago

Interventions

Dendritic Cell (DC) Injectionsbiological

* 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

Radiation therapyprocedure

Radiation was delivered 5 days per week (Monday-Friday).

Complete Resection - Surgery for tumor removalprocedure

Tumors were surgically resected 3-6 weeks after the completion of EBRT.