NY-ESO-1 Specific T Cells After Cyclophosphamide in Treating Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Withdrawn before enrolling · Phase 1

Conditions studied: Adult Synovial Sarcoma, Myxoid/Round Cell Liposarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

In brief

This phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1 specific T cells with cyclophosphamide may kill more tumor cells.

Key facts

Study ID

NCT02059850

Run by

Fred Hutchinson Cancer Center

People needed

0

Starts

2014-07-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• INCLUSION CRITERIA FOR SCREENING:
• Medical history including histopathological documentation of sarcoma
• Informed consent and Health Insurance Portability and Accountability Act (HIPAA) signing
• CRITERIA FOR LEUKAPHERESIS:
• NY-ESO-1 expression in tumor by immunohistochemistry (IHC) is not required prior to screening consent; however, patients must have NY-ESO-1 expression to proceed with the leukapheresis; additionally patients must also meet the following criteria to proceed with leukapheresis (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):
• Physical exam and Karnofsky performance status
• Laboratory evaluation:
• Complete blood count (CBC), differential and platelet count
• Basic metabolic and hepatic function panels
• Puget Sound Blood Center Recipient Donor Battery Panel
• Pregnancy test for females of child-bearing potential
• Pulse > 45 and < 120
• Weight >= 45 kg
• Temperature =< 38 Celsius (C) (=< 100.4 Fahrenheit [F])
• White blood cell (WBC) >= 2,000
• Hematocrit (HCT) >= 30%
• Platelets >= 75,000
• Research blood including 40 mL of blood in a heparinized tube for peripheral blood mononuclear cell (PBMC) collection and 10 mL of blood for serum collection (generally in a red top tube) within 30 days of leukapheresis collection
• INCLUSION CRITERIA FOR TREATMENT:
• A diagnosis of synovial sarcoma or myxoid/round cell liposarcoma
• Patients must have "advanced disease"; usually, this will mean metastatic disease; this may also be multiply recurrent disease or locally advanced disease; locally advanced disease is defined for this study as disease where a mutilating surgery is required and the patient is more likely than not to die of their disease despite an aggressive operation; patients with metastatic disease that has been resected or radiated are allowed to participate; Response Evaluation Criteria in Solid Tumors (RECIST) evaluable disease is not necessary for participation
• NY-ESO-1 positive by IHC (for this study, even a small level of positivity is acceptable); for patients with < 5% NY-ESO-1 by IHC positivity, the level of staining should be discussed with the patient and they should be informed that this will likely effect the efficacy of the therapy; this conversation must be documented in the patient's medical chart
• Human leukocyte antigen (HLA)-A0201 or HLA-A2402
• Zubrod performance status of '0-1'
• All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning

You may not qualify if…

• Patients for whom we are unable to generate NY-ESO-1 specific cells
• Pregnant women, nursing women, and 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
• Serum creatinine > 1.6 mg/dL or glomerular filtration rate < 50
• Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3 x upper limit of normal
• Bilirubin > 1.6 mg/dL
• Prothrombin time > 1.5 x control
• Active symptomatic congestive heart failure
• Clinically significant hypotension (systolic blood pressure [SBP] < 80 mm HG or symptomatic)
• Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 6 months will be allowed to participate
• Known untreated central nervous system (CNS) metastasis; patients with CNS metastasis will be allowed on study once treated
• Patients with active systemic infections requiring antibiotics or chronic maintenance/suppressive therapy; once the infection in question has resolved and patient is off antimicrobial treatment, patients may participate
• Systemic anticancer treatments (including chemotherapy and biologics) less than 3 weeks prior to T cell therapy; locally directed therapy (e.g. radiation) 2 weeks prior to cell infusion
• Known clinically significant autoimmune disorders requiring systemic immunosuppression for control
• Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible for this study
• Current treatment with steroids
• Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); (if a patient was not tested at the time of their leukapheresis, they must be tested prior to receiving T cell infusion; if testing was done for leukapheresis, this is adequate and does not need to be repeated)
• Patients with a known history of proven myocarditis, pericarditis, and/ or endocarditis

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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