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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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. 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. 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:

I. 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.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: 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 ]

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


Original Primary Outcome: Toxicity of cellular adoptive NY-ESO-1 specific T cell therapy in the context of this novel conditioning regimen incorporating low-dose IFN gamma [ Time Frame: Up to 10 weeks ]

Patients will be monitored for treatment-related toxicities. Toxicity grading will be evaluated according to guidelines in National Cancer Institute (NCI) Common Toxicity Criteria version 4.0. All unexpected grade 3, 4, and 5 toxicities will be reported descriptively. Toxicity will be reported descriptively.


Current Secondary Outcome: Antitumor efficacy as determined by CT scan [ Time Frame: After week 8 ]

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).


Original Secondary Outcome: Antitumor efficacy as determined by CT scan [ Time Frame: After 4 weeks and then 8-10 weeks post treatment ]

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: November 17, 2011
Date Started: January 2012
Date Completion:
Last Updated: December 9, 2014
Last Verified: December 2014