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Adult Synovial SarcomaPhase 1NCT02059850

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

A Phase 1 study testing Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Cyclophosphamide and Laboratory Biomarker Analysis in people with Adult Synovial Sarcoma and Myxoid/Round Cell Liposarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Cyclophosphamide and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2014to Jan 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • 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
  • All patients must have a stress test within 6 months of starting treatment showing no evidence of cardiac ischemia
  • All patients must have an echo or multi gated acquisition scan (MUGA) scan showing ejection fraction (EF) > 50% and normal troponin and creatine kinase (CK) myoglobin binding (MB) (echo may be done at the time of stress test as a stress echo); within 6 months of starting treatment; however if the patient has received cardiotoxic chemotherapy such as Adriamycin, they must have had an echo or MUGA scan since completing this treatment
  • If there is a patient with an NY-ESO-1 expressing soft tissue sarcoma who would be otherwise eligible for the trial, which is either not synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) or there is controversy about the diagnosis, eligibility will be decided by the PI
  • Patients must have NY-ESO-1 specific cells already produced or in production; these cells may be either in the process of their final expansion (for fresh infusion) or expanded and frozen at the time of enrollment

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Study to Determine the Feasibility of Treating Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Using Autologous NY-ESO-1 Specific CD8+ T Cells With Cyclophosphamide Pre-conditioning But Without the Use of IL-2

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To confirm the safety and efficacy of cancer-testis antigen (NY-ESO-1) specific T cells (autologous NY-ESO-1-specific cluster of differentiation [CD]8-positive T lymphocytes) in patients with advanced synovial sarcoma and myxoid/round cell liposarcoma following conditioning with high dose cyclophosphamide.

SECONDARY OBJECTIVES:

  1. To confirm the persistence of NY-ESO-1 tetramer positive cells in the peripheral blood at 10 weeks after T cell infusion for synovial sarcoma and myxoid/round cell liposarcoma patients receiving NY-ESO-1 specific T cells following cyclophosphamide conditioning but not post-infusion interleukin (IL)-2.

OUTLINE:

Patients receive cyclophosphamide intravenously (IV) on days -3 and -2 and NY-ESO-1 specific T cells IV over 60 minutes on day 0. Patients may receive additional infusions at the discretion of the Principal Investigator (PI).

After completion of study treatment, patients are followed up for up to 12 weeks.

Being tested
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Cyclophosphamide, Laboratory Biomarker Analysis
Medical subject headings
Sarcoma, Synovial, Liposarcoma, Myxoid, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous NY-ESO-1-specific CD8-positive T LymphocytesBiological

    Given IV

  • CyclophosphamideDrug

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02059850
Study groupRoleWhat they receive
Treatment (cyclophosphamide, NY-ESO-1 specific T cells)ExperimentalPatients receive cyclophosphamide IV on days -3 and -2 and NY-ESO-1 specific T cells IV over 60 minutes on day 0. Patients may receive additional infusions at the discretion of the PI.
Receives: Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes; Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of grade III or greater toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0

    The type and grade of toxicities noted during therapy will be summarized for each dose level. All adverse events noted by the investigator will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters.

    Measured: Up to 10 weeks

Secondary outcomes (2)

  1. Persistence of tetramer positive T cells

    The standard deviation and variance will be determined.

    Measured: At 4 weeks

  2. Persistence of tetramer positive T cells

    The standard deviation and variance will be determined.

    Measured: At 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059850
Sponsor's protocol ID
2720.00
Other IDs
NCI-2013-02464, 2720.00, K23CA175167, P30CA015704
Status last verified
Feb 2016
First submitted
7 Feb 2014
Last updated
3 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Cyclophosphamide and Laboratory Biomarker Analysis in people with Adult Synovial Sarcoma and Myxoid/Round Cell Liposarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade III or greater toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

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