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A Phase I Study To Determine the Feasibility of Using Autologous NY-ESO-1 Specific CD8+ T Cells For the Treatment of Patients With Advanced Myxoid/ Round Cell Liposarcoma and Synovial Sarcoma.

Phase 1
18 Years
Open (Enrolling)
Adult Liposarcoma, Adult Synovial Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

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Trial Information

A Phase I Study To Determine the Feasibility of Using Autologous NY-ESO-1 Specific CD8+ T Cells For the Treatment of Patients With Advanced Myxoid/ Round Cell Liposarcoma and Synovial Sarcoma.


I. Assess the feasibility, safety and toxicity of treating patients with NY-ESO-1 specific
cellular adoptive immunotherapy in myxoid/round cell liposarcoma (MRCL) and synovial sarcoma
patients receiving autologous CD8+ NY-ESO-1 specific T cells following cyclophosphamide


I. Evaluate the antitumor effect and persistence of adoptively transferred CD8+
antigen-specific cytotoxic T lymphocyte (CTL) lines following cyclophosphamide conditioning.


Patients receive cyclophosphamide intravenously (IV) on days -3 and -2. Patients receive
NY-ESO-1-specific T cells IV on day 0.

After completion of study treatment, patients are followed up for 8 weeks.

Inclusion Criteria:

- Histopathological documentation of the diagnosis of synovial sarcoma or myxoid
liposarcoma with metastatic or unresectable disease who have received an alkylating
agent containing regimen (such as doxorubicin plus Iphosphamide); this includes
patients who received an alkylating agent as part of adjuvant therapy and then
relapsed; patients who were treated on the PICCASSO trial who have progressed will be
allowed on the study; "unresectable disease" shall include patients with locally
advanced disease where a surgery could be attempted but where this surgery would be
mutilating, debilitating and would likely fail to result in long-term disease free
survival; in this setting a patient might reasonably choose to undergo salvage/second
line systemic therapy but could also pursue aggressive surgical options as standard
of care

- Able to tolerate high-dose cyclophosphamide

- NY-ESO-1 expression in > 25% of tumor by immunohistochemistry (IHC) (at least 2+)

- Expression of human leukocyte antigen (HLA)-A0201; high resolution HLA typing
performed at any experienced HLA lab will be accepted

- Zubrod performance status of '0-1'

- Patients with metastatic disease must have bi-dimensionally measurable disease by
palpation on clinical exam, or radiographic imaging (computed tomography [CT] scan)

- All patients must have an electrocardiogram (ECG); all patients must have a normal
stress test within 182 days prior to treatment

- Patients must have already been leukapheresed on either protocol 1246 or 2365 prior
to entry into this study; patients who are unable to have a leukapheresis product
collected, for whatever reason, will be unable to participate in this study

- If there is a patient with an NY-ESO-1 expressing sarcoma who would be otherwise
eligible for the trial, where there has been disagreement between pathologists
regarding the histopathologic diagnosis, eligibility will be decided on by the
principal investigator (PI)

- Patients must have had NY-ESO-1 specific cells already in production; patients must
have NY-ESO-1 specific cells that have been generated and sorted; these cells may be
either in the process of expansion or expanded and frozen at the time of enrollment

- Patients with definitively treated brain metastasis and patients with 4 or fewer
untreated lesions less than 1 cm each will be included at the discretion of the
principle investigator (PI)

- Patients must be off metformin at least 2 weeks before receiving T cell therapy

- Patients must have hemoglobin A1C < 8.5%

Exclusion Criteria:

- Patients for whom we are unable to generate NY-ESO-1 specific cells

- Pregnant women, nursing mothers, men or 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 entry

- Serum creatinine > 1.5 mg/dL or Glomerular Filtration Rate < 50

- Significant hepatic dysfunction (serum glutamic oxaloacetic transaminase [SGOT] > 150
IU or > 3x upper limit of normal [ULN])

- Bilirubin > 1.6 mg/dL

- Prothrombin time (PT) > 1.5 x control

- Most patients with metastatic sarcoma will have pulmonary metastasis and it is
expected that the majority will have some mild to moderate baseline shortness of
breath; these patients will be allowed on study so long as their Eastern Cooperative
Oncology Group (ECOG) performance status is 1; patients with severe pulmonary
dysfunction (>= Grade 3 Respiratory disorders as defined by Common Terminology
Criteria for Adverse Events [CTCAE] v4) will not allowed on study until their
condition improves; however, patients who have recently experienced a decrease in
their pulmonary function will be required to undergo pulmonary function testing;
patients with a forced expiratory volume in one second (FEV1) < 1.5L or diffusing
capacity of carbon monoxide (DLco) (corr for hemoglobin [Hgb]) < 50% will be
excluded; patients with a reversible cause of pulmonary dysfunction may undergo
repeat testing and enroll if their pulmonary function tests (PFT's) meet criterion

- All patients must have an echo showing ejection fraction (EF) > 50% and normal
troponin and creatine kinase (CK) MB (echo may be done at the time of stress test as
a stress echo); furthermore the following significant cardiovascular abnormalities
will be excluded:

- Active, symptomatic congestive heart failure

- Clinically significant hypotension

- Symptoms of coronary artery disease

- Presence of cardiac arrhythmias on EKG requiring drug therapy which has not been
stable for at least 6 months

- Patients with symptomatic untreated brain metastasis or asymptomatic untreated brain
metastasis > 1cm will not be allowed to participate; additionally, patients with five
or more untreated brain metastasis under 1 cm will not be allowed to participate;
treatment may include surgery or stereotactic radiation at the discretion of the
patient's treatment team; patients must be off steroids when starting therapy

- Patients with active infections or oral temperature > 38.2 C within 72 hours of study
entry or systemic infection requiring chronic maintenance or suppressive therapy

- Chemotherapeutic agents (standard or experimental or other immunosuppressive
therapies) less than 3 weeks prior to T cell therapy; (patients with bulky disease
may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3
weeks prior to T cell infusion); patients may receive palliative radiation therapy
two weeks prior to T cell infusion

- Clinically significant autoimmune disorders or conditions of immunosuppression;
patients with acquired immune deficiency syndrome (AIDS) or human immunodeficiency
virus (HIV)-1 associated complex or known to be HIV antibody seropositive or known to
be recently pathologic complete response (PCR)+ for hepatitis are not eligible for
this study; virology testing will be done within 6 months of T cell infusion; the
severely depressed immune system found in these infected patients and the possibility
of premature death would compromise study objectives

- Current treatment with steroids

- Patients must not be receiving any other experimental drugs within 3 weeks of the
initiation of treatment and must have recovered from all side effects of such therapy

- Patients who were not negative for hepatitis B virus (HBV), hepatitis C virus (HCV)
at the time of their leukapheresis on 1246 or 2365 must be retested to be sure they
are PCR negative

- Patients with a history of myocarditis, pericarditis, endocarditis

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility, safety and toxicity of treating patients with NY-ESO-1 specific T cell cellular adoptive immunotherapy

Outcome Description:

Patients will be monitored for treatment-related toxicities. Toxicity grading will be evaluated according to guidelines in National Cancer Institute (NCI) Common Toxicity Criteria version 4.0. All unexpected grade 3, 4, and 5 toxicities will be reported descriptively. Toxicity will be reported descriptively.

Outcome Time Frame:

Up to 10 weeks

Safety Issue:


Principal Investigator

Seth Pollack

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Adult Liposarcoma
  • Adult Synovial Sarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Liposarcoma
  • Sarcoma, Synovial
  • Sarcoma



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109