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

Completed · Phase 1

Conditions studied: Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID: NCT02180698
Run by: Fred Hutchinson Cancer Center
People needed: 16
Starts: 2014-11-17
Expected to finish: 2016-10-07
Last updated by the study team: 2019-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A diagnosis of metastatic or unresectable sarcoma
Patient must have a palpable, superficial tumor, safely accessible for bedside injection that will be radiated and can be accurately localized and stabilized if needed
Patient must have consulted with a radiation oncologist who is planning radiation; radiation should be completed within a 2-week window from start to finish
Patient must be willing to undergo biopsies as specified by the protocol; the biopsy requirement can only be waived if deemed unsafe by the patient's treating physician or the principal investigator (PI)
Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of '0-2'
Serum creatinine =< 1.5 times the upper limit of normal
Total bilirubin =< 1.5 times the upper limit of normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times the upper limit of normal
Prothrombin time (PT) =< 1.5 times the upper limit of normal
Partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal
Absolute neutrophil > 1000/uL
Platelet count > 75,000/uL
For patients who will be entering the "expansion phase" of the trial, the patient must be able to safely delay radiation by at least 6 weeks

You may not qualify if…

Pregnant women, nursing women, men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry
Known active symptomatic congestive heart failure
Known clinically significant hypotension
Known newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 3 months will be allowed to participate
Known untreated central nervous system (CNS) metastasis
Patients with known systemic infections requiring antibiotics or chronic maintenance/suppressive therapy
Systemic anticancer therapy (chemotherapy, "biologics", immunotherapy) less than two weeks prior to starting radiation
Known clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
Current treatment with steroids
Patients who are known to be human immunodeficiency virus (HIV) positive must have a normal cluster of differentiation (CD)4 count and undetectable viral load
Current treatment with warfarin; for patients not on an anti-platelet agent such as aspirin, other anticoagulation is acceptable so long as the treating physician feels that it is safe to hold it on the day of the biopsy until after the biopsy has been safely completed
Known allergy(ies) to any component of the study agent GLA-SE including egg lecithin

Where it is running

Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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