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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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 P

Brief 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. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. 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:

I. 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.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: 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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Persistence of tetramer positive T cells [ Time Frame: At 4 weeks ]
    The standard deviation and variance will be determined.
  • Persistence of tetramer positive T cells [ Time Frame: At 10 weeks ]
    The standard deviation and variance will be determined.


Original Secondary Outcome: Same as current

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: February 7, 2014
Date Started: July 2014
Date Completion:
Last Updated: February 1, 2016
Last Verified: February 2016