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Adult LiposarcomaPhase 1NCT01477021

Autologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery

A Phase 1 study testing cyclophosphamide, NY-ESO-1-specific T cells and laboratory biomarker analysis in people with Adult Liposarcoma and Adult Synovial Sarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies the side effects and how well giving autologous T cells with cyclophosphamide works in treating patients with soft tissue sarcoma that is metastatic or cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cyclophosphamide, NY-ESO-1-specific T cells and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jan 2012to Sep 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ifosphamide); 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)
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  • 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 principal investigator (PI)
  • Patients must be off metformin at least 2 weeks before receiving T cell therapy
  • Patients must have hemoglobin A1C < 8.5%

Who cannot join

  • 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
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  • 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] version [v]4) 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) (corrected [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 echocardiogram (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 > 1 cm 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

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 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.

This phase I trial studies the side effects and how well giving autologous T cells with cyclophosphamide works in treating patients with soft tissue sarcoma that is metastatic or cannot be removed by surgery. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving autologous T cells together with cyclophosphamide may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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 cluster of differentiation (CD)8+ NY-ESO-1 specific T cells following cyclophosphamide conditioning.

SECONDARY OBJECTIVES:

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

OUTLINE:

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.

Being tested
cyclophosphamide, NY-ESO-1-specific T cells, laboratory biomarker analysis
Medical subject headings
Liposarcoma, Sarcoma, Synovial, Sarcoma

What participants receive

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

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • NY-ESO-1-specific T cellsBiological

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01477021
Study groupRoleWhat they receive
Treatment (NY-ESO-1 specific CD8+ T cells)ExperimentalPatients receive cyclophosphamide IV on days -3 and -2. Patients receive NY-ESO-1-specific T cells IV on day 0.
Receives: Drug: cyclophosphamide; Biological: NY-ESO-1-specific T cells; Other: laboratory biomarker analysis

What is being measured

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

  1. Incidence of treatment-related toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Patients will be monitored for treatment-related toxicities. All unexpected grade 3, 4, and 5 toxicities will be reported descriptively.

    Measured: Up to 10 weeks

Secondary outcomes (1)

  1. Antitumor efficacy as determined by CT scan

    Radiographic imaging and clinical assessment of residual disease will be compared with pre-infusion assessment. A complete response (CR) will be defined as total regression of all tumor, a partial response (PR) as 30% or greater decrease in the sum of the longest diameter of target lesions and progressive disease (PD) as 20% increase in the sum of the longest diameter of target lesions (RECIST criteria).

    Measured: After week 8

Timeline

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

  1. First posted22 Nov 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2013

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01477021
Sponsor's protocol ID
2537.00
Other IDs
NCI-2011-03549, 2537.00, P30CA015704
Status last verified
Dec 2014
First submitted
17 Nov 2011
Last updated
11 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cyclophosphamide, NY-ESO-1-specific T cells and laboratory biomarker analysis in people with Adult Liposarcoma and Adult Synovial Sarcoma, 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 13 inclusion and 20 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: finished, as of the sponsor's last update on 11 Dec 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 treatment-related toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events 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 NCT01477021.

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 11 Dec 2014.

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