NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy
NCT ID: NCT02319824
Last Updated: 2017-07-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (radiation and NY-ESO-1-specific T cells)
Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV over 60 minutes 2-3 days after completion of radiation therapy.
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Given IV
Laboratory Biomarker Analysis
Correlative studies
Palliative Radiation Therapy
Undergo palliative radiation therapy
Interventions
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Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
Given IV
Laboratory Biomarker Analysis
Correlative studies
Palliative Radiation Therapy
Undergo palliative radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Seth Pollack
Responsible Party
Principal Investigators
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Seth Pollack
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2014-02154
Identifier Type: REGISTRY
Identifier Source: secondary_id
2721
Identifier Type: -
Identifier Source: secondary_id
2721.00
Identifier Type: OTHER
Identifier Source: secondary_id
2721.00
Identifier Type: -
Identifier Source: org_study_id
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