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Sarcoma

Autologous T Cells, Recombinant IFN Gamma, Cyclophosphamide and Aldesleukin for Metastatic Soft Tissue Sarcoma (2537)
A Phase I Study To Determine the Safety of Autologous NY-ESO-1 Specific CD8+ T Cells For Patients With Advanced Myxoid/ Round Cell Liposarcoma and Synovial Sarcoma in the Context of A Novel Regimen Combining Low Dose Weekly IFN-gamma With Cyclophosphamide Conditioning and Post-Infusional Low Dose IL-2
Status Conditions Phase Study ID
Closed Soft Tissue Sarcoma Phase I 2537
NCT01477021
Summary

This phase I trial studies the side effects of giving autologous T cells together with low-dose recombinant interferon (IFN) gamma, cyclophosphamide, and low-dose aldesleukin 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. Recombinant IFN gamma may interfere with the growth of cancer cells. 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. Aldesleukin may stimulate the white blood cells to kill soft tissue sarcoma cells. Giving autologous T cells together with recombinant INF gamma, cyclophosphamide, and aldesleukin may kill more tumor cells


Investigator
Seth Pollack, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Histopathological documentation of the diagnosis of synovial sarcoma and 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
  • Able to tolerate high-dose cyclophosphamide
  • NY-ESO-1 expression in > 25% of tumor by immunohistochemistry (IHC) (at least 2+); NY-ESO-1 staining may be done at any Clinical Laboratory Improvement Amendments (CLIA) certified lab
  • 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'
  • Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (computed tomography [CT] scan)
  • All patients must have an electrocardiogram (ECG); patients with a history of cardiac disease, diabetes or with ongoing chest pain or with an abnormal ECG must have a normal cardiac stress test within 182 days prior to treatment
  • Patients must be willing and able to discontinue the use of all antihypertensive medications 24 hours prior to and during IL2 therapy
  • 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 which have been generated and sorted; these cells may be either in the process of expansion or expanded and frozen at the time of enrollment
Exclusions (conditions that would prevent participation in this study)
  • Patients for whom we are unable to generate NY-ESO-1 specific cells from
  • 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 > 1.6 mg/dL or creatinine clearance < 75 ml/min
  • 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
  • Patients with pulmonary dysfunction as determined by history and physical examination will be required to undergo pulmonary function testing (PFT's) other patients are not required to undergo PFT's; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) < 2.0 L or diffusion capacity of carbon monoxide (DLco) (corr for hemoglobin [Hgb]) < 75% will be excluded; patients with a reversible cause of their pulmonary dysfunction will be allowed on study if they have repeat PFT's no longer meeting these criterion
  • Significant cardiovascular abnormalities as defined by any one of the following:

    • 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 active, ongoing fatigue or shortness of breath or those with a history of congestive heart failure must have an echo within 30 days of enrollment showing ejection fraction (EF) >50%
  • Patients with untreated central nervous system (CNS) metastasis will not be allowed to participate however patients with one or two isolated CNS metastasis may enter the study once these have been treated either surgically or with radiation (stereotactic or otherwise)
  • 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), radiation therapy, 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 therapy)
  • 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 2355 must be retested to be sure they are PCR negative
Last Updated
December 21, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.