TLR4 Agonist GLA-SE and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma That Is Metastatic or Cannot Be Removed by Surgery

Stage IV Adult Soft Tissue Sarcoma Clinical Trial

Official title: A Phase I Study to Determine the Safety of the Combination of Stable-Emulsion Formulation of Glucopyranosyl Lipid A (GLA-SE) With Radiation in Patients With Metastatic Sarcoma

Status Completed

Clinical Trial Summary

This pilot phase I clinical trial studies the side effects and best dose of toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given together with radiation therapy in treating patients with soft tissue sarcoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). TLR4 agonist GLA-SE may stimulate the immune system to kill sarcoma cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving TLR4 agonist GLA-SE with radiation therapy may be a better treatment to treat sarcoma that cannot be removed by surgery.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the safety of weekly injections of GLA-SE (TLR4 agonist GLA-SE) in combination with palliative radiation in patients with metastatic sarcoma.

SECONDARY OBJECTIVES:

I. To look for preliminary evidence of efficacy at distant tumor sites following the combination of radiation and intra-tumor injection of GLA-SE.

II. To analyze changes in tumor-immune infiltrates following radiation and intra-tumor injection of GLA-SE.

OUTLINE: This is a dose-escalation study of TLR4 agonist GLA-SE.

Patients receive TLR4 agonist GLA-SE intratumorally once weekly for 8 weeks. Within 2 weeks of starting treatment, patients also undergo radiation therapy over 2 weeks for a total of 5-6 fractions.

After completion of study treatment, patients are followed up every 6 weeks for 6 months and then every 3 months for up to 1 year. ;

Related Conditions & MeSH terms

• Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

• NCT number: NCT02180698
• Study type: Interventional
• Source: Fred Hutchinson Cancer Research Center
• Status: Completed
• Phase: Phase 1
• Start date: November 17, 2014
• Completion date: October 7, 2016