Expired Study
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Seattle, Washington 98109


Purpose:

This pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that have spread to other places in the body and are receiving palliative (relief of symptoms and suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into white blood cells may help the body build an immune response to kill tumor cells that express NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live more comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy may be a better treatment for patients with sarcomas.


Study summary:

PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity of NY-ESO-1-specific T cells when given following high-dose, hypo-fractionated palliative radiation to patients with advanced NY-ESO-1 expressing sarcomas. SECONDARY OBJECTIVES: I. To look for preliminary evidence of systemic efficacy of NY-ESO-1-specific T-cell therapy following radiation on non-radiated tumors. II. To determine whether radiation increases trafficking of adoptively transferred NY-ESO-1-specific T cells by comparing tumor biopsy specimens from radiated and non-radiated tumors. OUTLINE: Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells intravenously (IV) over 60 minutes 2-3 days after completion of radiation therapy. After completion of study treatment, patients are followed up weekly for 2 weeks, at 4-6, 8, 10, and 12 weeks, and then for up to 6 months.


Criteria:

Inclusion Criteria: INCLUSION CRITERIA FOR SCREENING: - Histopathological documentation of sarcoma - Patients must express NY-ESO-1 in their tumor by immunohistochemistry (IHC) (> 5%) prior to leukapheresis - For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the apheresis director and principal investigator [PI]): - Pulse > 45 or < 120 - Weight >= 45 kg - Temperature =< 38° Celsius (C) (=< 100.4° Fahrenheit [F]) - White blood cell count (WBC) >= 2,000 - Hematocrit (HCT) >= 30% - Platelets >= 75,000 INCLUSION CRITERIA FOR TREATMENT: - A diagnosis of a metastatic or unresectable sarcoma - Patient must have a biopsy-accessible tumor to be radiated - Patient must have consulted with a radiation oncologist who is planning radiation; their radiation oncologist should have documented plans to administer a dose of at least 30 Gy in 5 or fewer fractions - Human leukocyte antigen (HLA) type A0201 or A2402 - Zubrod (Eastern Cooperative Oncology Group [ECOG]) performance status of '0-2' - All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning - All patients must have an echo or multigated acquisition (MUGA) scan showing ejection fraction (EF) > 50% and normal troponin and creatine kinase MB (CK MB) performed within 90 days of starting treatment Exclusion Criteria: EXCLUSION CRITERIA FOR SCREENING: - Patients who do not meet the above inclusion criteria will not receive leukapheresis EXCLUSION CRITERIA FOR TREATMENT: - Patients with a history of proven myocarditis, pericarditis, or endocarditis - 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 - Inadequate renal function as indicated by serum creatinine >= 1.5 times the upper limit of normal - Inadequate liver function as indicated by 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 - Active symptomatic congestive heart failure - Clinically significant hypotension - 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 systemic infections requiring antibiotics or chronic maintenance/suppressive therapy - Patients receiving systemic anticancer therapy (chemotherapy, "biologics", immunotherapy) less than 2 weeks prior to starting radiation - Clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control - Patients with acquired immunodeficiency syndrome (AIDS) or who are known to be human immunodeficiency virus (HIV) positive are not eligible for this study; testing may have been done up to 3 months prior to treatment - Current treatment with steroids - Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); testing may have been done up to 3 months prior to treatment


NCT ID:

NCT02319824


Primary Contact:

Principal Investigator
Seth Pollack
Fred Hutch/University of Washington Cancer Consortium


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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