Autologous T Cells and Cyclophosphamide in Treating Patients With Soft Tissue Sarcoma That is Metastatic or Cannot Be Removed By Surgery
|Adult Liposarcoma Adult Synovial Sarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma||Drug: cyclophosphamide Biological: NY-ESO-1-specific T cells Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- 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.
- 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).
|Study Start Date:||January 2012|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (NY-ESO-1 specific CD8+ T cells)
Patients receive cyclophosphamide IV on days -3 and -2. Patients receive NY-ESO-1-specific T cells IV on day 0.
Other Names:Biological: NY-ESO-1-specific T cells
Given IVOther: laboratory biomarker analysis
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.
I. Evaluate the antitumor effect and persistence of adoptively transferred CD8+ antigen-specific cytotoxic T lymphocyte (CTL) lines following cyclophosphamide conditioning.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477021
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Seth Pollack||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|